- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07258342
Evaluering af nedre ekstremitetsinterventioner hos personer med kronisk apopleksi
Evaluering af effekterne af lukkede kinetiske kædeøvelser og Kinesio Taping på underkroppen hos personer med kronisk apopleksi
Denne undersøgelse har til formål at evaluere effektiviteten af lukkede kinetiske kæde (CKC) øvelser og kinesio taping på knæledsproprioception, balance, funktionel præstation og livskvalitet hos personer med kronisk apopleksi. Apopleksi resulterer ofte i proprioceptive mangler og forstyrrelser i postural kontrol, som negativt påvirker rehabiliteringsresultater. Mens CKC-øvelser menes at forbedre proprioceptiv input gennem ledkompression og sensorisk feedback, anvendes kinesio taping som en komplementær intervention for at støtte motorisk kontrol og stabilitet. Undersøgelsen vil sammenligne effekterne af disse to interventioner for at afgøre deres potentielle roller i forbedring af sensorimotorisk funktion og fremme af funktionel uafhængighed i apopleksirehabilitering.
I alt 30 deltagere blev indskrevet i denne undersøgelse.
Inklusionskriterier:
- Patienter, der har haft apopleksi for mere end 6 måneder siden,
- Har en stabil medicinsk tilstand,
- Evne til at forstå enkle instruktioner,
- Personer med spasticitet mellem grad 0-2 ifølge den modificerede Ashworth-skala,
- Personer, der kan gå selvstændigt eller med hjælpemidler,
- Dem, der accepterer at deltage og overholde undersøgelsesprocedurerne.
Eksklusionskriterier:
- Svær kognitiv svækkelse (MMSE-score < 24),
- Ortopædiske tilstande, der kan forårsage knæsmerter under træning,
- Andre neurologiske tilstande, der kan påvirke proprioception,
- Svær ledkontraktur,
- Afvisning eller uvillighed til at deltage i undersøgelsen.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Stroke is defined as a sudden loss of neurological function lasting more than 24 hours, occurring in central nervous system regions such as the brain, spinal cord, or retina, due to infarction or hemorrhage. Etiologically, stroke is classified into two main groups: hemorrhagic and ischemic. Ischemic stroke occurs due to insufficient blood flow to cerebral tissue, while hemorrhagic stroke is characterized by bleeding into brain tissue or the subarachnoid space. Of all stroke cases, approximately 44% occur in men and 56% in women. The prevalence of stroke is around 22% in individuals aged 15 to 49 and increases to 67% when examined up to the age of 70.
The post-stroke period is typically divided into phases. The Stroke Roundtable Consortium recommends the following classification: the first 24 hours as the hyperacute phase, the first 7 days as the acute phase, the first 3 months as the early subacute phase, months 4 to 6 as the late subacute phase, and after 6 months as the chronic phase.
Following a stroke, patients commonly experience postural control loss, asymmetric weight distribution, abnormal gait patterns, and balance impairments, all of which negatively affect functional independence and quality of life.
Sensory deficits are also prevalent in stroke patients, with exteroception affected in 7-53%, proprioception in 34-64%, and higher cortical functions in 31-89% of cases. Most patients experience impairments in multiple types of sensation. These sensory disturbances reduce the feedback received from objects, potentially leading to non-use of the affected limb. Among these, proprioceptive deficits pose significant challenges during rehabilitation. Studies have shown that reduced proprioception in individuals with stroke negatively affects motor control and should be addressed in rehabilitation programs.
Progressive resistance exercise has been shown to be an effective treatment for strengthening weak muscles caused by various musculoskeletal and neuromuscular disorders. It is a training method that gradually increases the level of resistance to improve force generation capacity. Closed kinetic chain (CKC) and open kinetic chain (OKC) exercises are two widely used progressive resistance training methods aimed at improving proprioception and motor functions in stroke patients. CKC exercises are believed to enhance proprioception by providing greater sensory feedback through joint position sense and mechanoreceptor activation.
CKC exercises are typically performed with the terminal segment of a limb fixed and in continuous contact with a surface, resulting in compressive forces through the joints of the lower extremities. In contrast, OKC exercises are performed with the terminal segment of the limb free to move and are reported to primarily increase muscle strength rather than improve proprioception during movements like knee flexion and extension. Previous studies suggest that CKC exercises may offer more sensory input, thereby enhancing sensorimotor functions, including motor control and joint proprioception, more effectively than OKC exercises.
Kinesio taping, a method that can improve function in stroke patients, is used as a complementary treatment due to its positive effects on postural control, muscle strength, mobility, balance, and gait patterns. However, most previous studies have focused on ankle joint applications of kinesio taping, and only a limited number have examined its effects on proprioception, postural control, and gait when combined with proprioceptive training targeting the knee joint in stroke patients.
Proprioceptive training, as a method that enhances proprioception in stroke patients, is mainly utilized to determine the effectiveness of new rehabilitation approaches.
The aim of this study is to evaluate knee joint position sense in individuals with chronic stroke and to comparatively examine the effectiveness of closed kinetic chain exercises and kinesio taping in improving this sense. The study aims to assess the effects of these two interventions on proprioception, balance, functional performance, and quality of life.
The post-stroke recovery process, while individual differences persist, is examined in three main phases: acute, subacute, and chronic. The chronic stroke phase is generally defined as the period six months or more after the stroke and is the phase in which the patient's functional status stabilizes. However, the potential for recovery continues during this phase with neuroplasticity and rehabilitation interventions.
Neurological recovery (Neuroplasticity) refers to the structural and functional reorganization of the brain. Neuroplasticity occurs as an adaptive response to brain damage. This process involves the restructuring of nerve cells, glial cells, and axons. These mechanisms are most intense in the early stages of post-stroke recovery, especially in the first six months (88).
Recovery from stroke occurs through mechanisms such as neuroplasticity, the reorganization of adjacent brain regions, the strengthening of synaptic connections, and the activation of alternative neural pathways (89).
Functional recovery refers to individuals becoming more independent in their daily activities. Post-stroke recovery generally begins rapidly in the first six months and shows significant improvement within a year (90). Functional recovery depends not only on neurological recovery but also on the environmental and psychological interactions of patients. Patients typically experience a decrease in muscle tone (flaccid phase) initially after a stroke. However, this phase typically gives way to a spastic phase with increased muscle tone. This transition begins within 2-4 weeks. A prolonged flaccid phase and a late onset of tone increase indicate a poor recovery prognosis. Furthermore, delayed return of reflexes, excessive proximal muscle tone, and the absence of voluntary hand movement negatively impact the expectation of functional recovery (88). Post-stroke recovery generally progresses from proximal to distal, with the highest potential for recovery within the first 6 months. During this period, 80% of individuals require rehabilitation, 10% do not benefit from treatment, and another 10% may recover spontaneously (91).
Many factors influence recovery and functional outcomes:
- Stroke location and size: Cortical strokes generally have a worse prognosis than subcortical strokes (92).
- Early motor function status: Motor function level in the first weeks is the strongest predictor of long-term functional recovery (93).
- Age: Younger patients have a higher potential for recovery (94).
- Cognitive and psychosocial status: Depression, lack of motivation, and cognitive impairments negatively impact rehabilitation success (95).
4.10 The Importance of Physiotherapy and Rehabilitation in Chronic Stroke During this period, the patient may have regained much of the movement lost due to the stroke. Tone may be approaching normal, but significant deficits in timing and coordination skills are evident. Physical therapy goals are the cornerstone of stroke rehabilitation, encompassing a multifaceted approach aimed at restoring mobility, improving motor function, and alleviating physical impairments. The goals include restoring normal walking and stair activities, improving manual dexterity and grasping abilities, and improving cardiorespiratory endurance. (96,97) Stroke treatment begins with the patient's clinical condition stabilizing. Early intervention helps preserve brain tissue and supports the penumbra. It also prevents learned disuse and compensatory strategies, allowing the neuroplasticity process to progress properly (98). In the acute phase, it is important to protect the patient from complications. During this period, the goal is to prevent potential complications such as pneumonia, deep vein thrombosis, pulmonary embolism, and cardiac arrhythmias. Early mobilization, in-bed exercises, positioning, and cardiopulmonary rehabilitation approaches support the patient's functional recovery. For patients transitioning to the subacute phase, more advanced rehabilitation methods are implemented. During this period, exercises aimed at improving mobility, balance, sitting training, and upper extremity function and sensory integration are implemented. At the same time, treatment continues in parallel with areas such as occupational therapy, speech and language therapy, swallowing rehabilitation, and cognitive rehabilitation.
In the chronic phase, comprehensive rehabilitation approaches tailored to the patient's needs continue through inter- and multidisciplinary teamwork and home programs. Any existing complications are treated (47). Therapists use various balance exercises and proprioceptive activities to improve the balance and coordination necessary to prevent falls and maintain functional mobility. These exercises generally involve challenging the patient's balance in a controlled environment to improve balance reactions and postural control (99).To reduce the risk of secondary complications such as joint contractures and stiffness, therapists incorporate range-of-motion exercises. These exercises aim to maintain joint flexibility, prevent musculoskeletal problems, and facilitate range of motion in the affected limbs (91,100). They extend beyond clinical settings to include functional training and home modification recommendations. The therapist collaborates with patients to simulate activities important to daily living through practice. Additionally, they provide guidance on adapting their home environment and recommend assistive devices and modifications to improve accessibility and safety in the home environment. (101,102) 4.11 Physiotherapy Rehabilitation Approaches in Chronic Stroke Rehabilitation interventions in the chronic phase generally include community-based programs that provide ongoing therapy and support. PNF patterns and repetitive contractions can be used. Controlled eccentric contractions are necessary to restore normal function. Protective extension reactions should be introduced. (103) Balance and gait training should be performed at different speeds and difficulties. Advanced therapies such as robot-assisted therapy and virtual reality training are used to improve motor skills and cognitive functions. Biofeedback can be used to prompt the patient to perform voluntary muscle contractions in weak muscles. (104,105) Functional electrical stimulation (FES) can be used to improve muscle function, and mirror therapy can be used to create the illusion of movement in the affected limb. (106) Cognitive rehabilitation activities are designed to improve memory, attention, and problem-solving skills. Aerobic exercises and hydrotherapy are included to improve cardiovascular health and overall fitness (71). Music therapy can be beneficial for improving mood and cognitive function (107). Long-term psychological support is crucial for helping patients adapt to their new normal and maintain their motivation to continue their recovery (108).
Methods applied in stroke rehabilitation can be categorized as neurophysiological approaches, conventional treatments, and functional treatments.
Among neurophysiological approaches, the Proprioceptive Neuromuscular Facilitation (PNF) technique, which aims to improve motor control and muscle function by facilitating and relearning motor responses through proprioceptive stimulation, is one of the most popular. The Bobath approach, which utilizes the brain's neuroplasticity to reduce abnormal movement patterns and support the regaining of normal motor functions, is among the most popular approaches. Additionally, the Brunnstrom method and the Johnstone and Rood approach are also among the neurophysiological approaches.
Conventional treatments include range of motion, strengthening and stretching exercises, balance and coordination and gait training, thermotherapy methods, electrotherapy agents, orthotic approaches, manual therapy techniques, and mat exercises.
Functional approaches, on the other hand, include various technological approaches such as mirror therapy, forced restraint therapy and biofeedback, virtual reality applications, and robot-assisted rehabilitation. (48,109,110) 4.12 Sensory Impairment in Chronic Stroke Stroke is a sudden and focal lesion of the central nervous system and usually results from occlusion or hemorrhage in cerebral vessels. In the post-stroke period, in addition to motor function losses, significant impairments in the sensory system are observed. These sensory system impairments severely limit patients' ability to maintain activities of daily living and create significant challenges in the rehabilitation process. (111) The Role of the Sensory System in Stroke: The primary functions of the sensory system include superficial sensations such as touch, pain, and temperature, as well as deep sensations such as proprioception and vibration. Depending on the location of the stroke lesion, damage to any or more of these senses may occur. Proprioceptive impairments, in particular, are critical for motor control because knowing the position of muscles and joints is essential for coordination and balance (8).
Studies in chronic stroke patients have shown that the rate of superficial and deep sensory loss ranges from 30% to 50%, negatively impacting functional recovery (111). Proprioceptive impairment is associated with balance problems, gait disturbances, and an increased risk of falls (112).
Clinical Manifestations of Sensory Disorders: In chronic stroke, sensory impairments manifest in various ways. These disorders include hypesthesia (diminished sensation), paresthesia (abnormal sensation), decreased pain sensation, and decreased proprioceptive awareness. The location of the lesion also determines the type of sensory loss. For example, lesions to the thalamus or somatosensory cortex often cause severe superficial and deep sensory loss (113). These sensory impairments make it difficult for patients to recognize objects, coordinate their movements, and maintain balance. They negatively impact independence, particularly in activities of daily living, leading to a decrease in quality of life.
The Importance of the Sensory System in Rehabilitation: In chronic stroke rehabilitation, restoring sensory functions is as crucial as improving motor functions. The literature has shown that sensory stimulation and proprioceptive training programs have positive effects on improving motor functions (114). Stimulating the proprioceptive system promotes neuroplasticity, supports motor learning, and contributes to functional recovery. Furthermore, various studies have reported that closed kinetic chain exercises and sensory-based movement training are effective in strengthening the proprioceptive system (115). These exercises increase somatosensory input by stimulating joint and muscle receptors and improve balance and postural control. 4.13 Treatments for Knee Joint Sensation in Chronic Stroke
Decreased knee joint proprioception in chronic stroke patients is primarily due to two main factors: damage to somatosensory pathways in the central nervous system and inadequate stimulation of peripheral mechanoreceptors. Stroke damages the somatosensory cortex and brain regions responsible for processing sensory information from the joint, leading to impaired proprioceptive perception (114). Furthermore, post-stroke muscle tone changes, spasticity, and movement limitations reduce the stimulation of mechanoreceptors around the knee, leading to decreased sensory signals at the spinal and brainstem levels (116). In light of these pathological processes, the goal of chronic stroke rehabilitation is to reactivate and reorganize both central and peripheral sensory systems. The treatment methods used for this include:
Kinesio Taping Closed Kinetic Chain Exercises: Closed kinetic chain exercises involve moving the knee joint in functional positions, supporting the patient's body weight. These exercises activate muscle and joint receptors surrounding the knee, increasing stimulation of mechanoreceptors and enhancing proprioceptive input. Closed kinetic chain exercises have been shown to provide significant improvements in balance and proprioception in chronic stroke patients (115).
Manual Therapy and Joint Mobilizations: These techniques increase the sensitivity of mechanoreceptors through controlled movements applied to the knee joint capsule and surrounding tissues. This increases joint range of motion and supports proprioceptive perception. Manual therapy enhances peripheral sensory signals, enabling more effective input to the central nervous system (114,116).
Functional Electrical Stimulation: FES increases muscle activity through electrical stimulation of the muscles and stimulates sensory nerves surrounding the knee. This method supports both motor learning and improves sensory information flow. It has been reported that FES-assisted rehabilitation improves proprioceptive functions and walking performance in chronic stroke patients (117).
Virtual Reality (VR)-Based Rehabilitation: VR environments enhance sensory-motor integration by providing patients with real-time visual and auditory feedback. This supports brain plasticity and promotes restructuring in the somatosensory system. VR-assisted treatments have been shown to significantly improve lower extremity sensory functions and balance in chronic stroke patients (118).
Complementary Methods (Vibration Therapy and Neurofeedback): These methods aim to increase patients' sensory awareness. Vibration therapy provides direct stimulation of mechanoreceptors, while neurofeedback supports sensory-motor learning processes by facilitating patient control of their own neural activity (116).
In conclusion, decreased knee joint proprioception after chronic stroke is due to changes in both the central and peripheral nervous systems. Therefore, the rehabilitation process aims to reorganize the sensory and motor systems together by combining different treatment modalities.
4.13.1 Benefits of Closed Kinetic Chain Exercises Closed Kinetic Chain (CKC) exercises simultaneously target both stability and functionality through constant contact of the extremity with the support surface. One of the greatest advantages of these exercises is their potential to stimulate neuroplasticity by simultaneously activating cortical and subcortical areas due to their multi-joint movements (119). CKC exercises, especially for the lower extremities (e.g., squat, step-up, mini lunge), support the reactivation of weakened muscles on the hemiplegic side while also strengthening sensorimotor integration.Thus, both muscle strength and muscle control are improved (120). Research has shown that CKC exercises reduce asymmetrical posture patterns in post-stroke patients, balance weight transfer, and increase gait symmetry (121). Kang and Kim (2013) reported significant improvements in static and dynamic balance skills in stroke patients who underwent CKC exercises (120). CKC exercises also improve lower extremity positional perception by increasing proprioceptive feedback. Knee joint proprioception, which is frequently impaired after stroke, can be restored through closed-chain exercises, particularly in weight-bearing positions (115). This directly contributes to reducing the risk of falls and promoting safe mobility. Another study found significant improvements in objective measures such as the Fugl-Meyer Motor Score, the Timed Up and Go test, and the Berg Balance Scale in individuals who underwent CKC exercises.
KC exercises also increase patient motivation and participation in rehabilitation thanks to their focus on functional goals, reducing secondary complications related to fatigue and inactivity. Furthermore, these exercises, which integrate sensorimotor and cognitive inputs, provide broader neurological benefits by affecting both upper and lower motor neuron systems (122). Consequently, closed kinetic chain exercises not only increase muscle strength, but also strengthen proprioception, improve balance, functionally improve gait, and support recovery in the central nervous system, providing a multidimensional contribution to the post-stroke rehabilitation process.
4.13.2 Benefits of Kinesiotaping Kinesiotaping is a treatment method that uses flexible, elastic tape applied to the skin and aims to have multiple effects on the musculoskeletal and nervous systems. Considering the motor deficits, tone imbalances, proprioceptive deficits, and functional disabilities that occur after stroke, kinesio taping stands out as a supportive rehabilitation modality, especially in the chronic phase (11).
One of the most common problems in individuals with chronic stroke is imbalance resulting from muscle weakness and increased tone on the hemiplegic side. Kinesio taping stimulates mechanoreceptors on the skin in the applied area, increasing proprioceptive feedback and helping to normalize muscle activity. The basis of this effect is the activation of nerve endings by the micro-tension created by the tape on the skin, thus increasing the sensory impulse sent to the central nervous system (12).
Recent studies have reported that kinesiotaping leads to significant improvements in areas such as posture control, balance, walking speed, and pain management in chronic stroke patients. Kinesiotaping applied around the knee has been shown to improve static and dynamic balance in hemiplegic individuals (123). Application of taping on the ankle has been reported to improve gait symmetry and standing time (124). Another recent study found that kinesiotaping applied to individuals experiencing shoulder subluxation after stroke reduced pain and improved functional range of motion by increasing shoulder stability (125). These results demonstrate that the support and postural correction effects it provides to the musculoskeletal system are not limited to the lower extremities. Furthermore, the application of kinesiotaping in conjunction with conventional physiotherapy leads to more significant functional improvements. It is emphasized that it opens up new possibilities. Comparative studies have reported that when taping is added to exercise programs, higher Berg Balance Score, Timed Up and Go time, and 10-Meter Walk Test scores are achieved compared to groups receiving exercise alone (123).
Kinesio taping is an effective complementary approach in chronic stroke rehabilitation because it is non-invasive, easy to apply, cost-effective, and has high patient compliance. However, application techniques based on accurate anatomical knowledge and tailoring to the individual patient profile are decisive factors in its effectiveness.
4.14 Assessment of Knee Joint Sensation Knee joint sensation is a fundamental component of motor control, particularly in terms of proprioception, movement, and position perception. Impairments in knee joint sensation can occur in chronic stroke, orthopedic injuries, and other neurological conditions. Therefore, accurate and systematic assessment of knee joint sensation is important for treatment planning and monitoring the rehabilitation process. Passive and Active Position Sense Tests (Joint Position Sense - JPS): The knee is moved passively or actively at certain angles. The patient is asked to estimate the position of the knee. Proprioception is evaluated by measuring the accuracy of position perception. (126)Motion Detection Threshold Test (TTDPM): Passive movement of the knee is initiated at very small angles. The patient's time to detect movement and sensitivity are recorded. (127) Vibration Sense Tests: Vibration is applied to the relevant area of the knee. Vibration perception ability is assessed and nerve and proprioceptive function is measured. (128) Functional Tests Berg Balance Scale (BBS): Measures static and dynamic balance performance. Time Up and Go (TUG) Test: Assesses functional mobility. Balance Platform and Gait Analysis: Dynamic balance and gait symmetry measurements are performed.
1.5. Electrophysiological Tests: Contributes to the assessment of proprioceptive functions by measuring nerve conduction velocity and reflex responses.
Evaluation of knee joint sensation with objective and functional measurements is critical for monitoring treatment effectiveness and for personalized rehabilitation planning. Proprioceptive losses are closely related to balance disorders and walking problems; Therefore, early and accurate evaluation is necessary for functional recovery.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Bakırköy
-
Istanbul, Bakırköy, Tyrkiet (Türkiye), 34147
- Özel İncirli Akademi Özel eğitim ve rehabilitasyon merkezi
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Patienter, der har haft et slagtilfælde for mere end 6 måneder siden,
- Personer med en medicinsk stabil tilstand,
- Evne til at forstå enkle instruktioner,
- Personer med spasticitet graderet mellem 0 og 2 på den modificerede Ashworth-skala,
- Personer, der kan gå selvstændigt eller med hjælpemidler,
- Personer, der er villige til at deltage i studiet og kan overholde studieprocedurerne.
Eksklusionskriterier:
- Alvorlig kognitiv svækkelse (Mini-Mental Test score < 24),
- Ortopædiske tilstande, der kan forårsage knæsmerter under træning,
- Andre neurologiske tilstande, der kan påvirke proprioception,
- Alvorlig ledkontraktur,
- Personer, der ikke ønsker at deltage frivilligt i studiet.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: gruppen, der deltog i lukkede kinetiske kædeøvelser
Lukkede kinetiske kædeøvelser for den nederste ekstremitet udføres typisk med fødderne fastgjort til et stabilt objekt, der genererer kompressionskræfter ved hofte-, knæ- og ankelleddene.
Deltagerne vil udføre lukkede kinetiske kædeøvelser i sessioner på 40 minutter to gange om ugen i 8 uger.
Hver øvelse gentages 3 til 5 gange, afhængigt af den enkeltes styrke. Øvelserne omfatter: væg-squats, fremadrettede og opadrettede step-ups, side- og opadrettede step-ups, dobbeltbens-squats, broer og kvadriceps-isometriske styrkeøvelser.
|
Ledstillingsevnen vil blive vurderet ved hjælp af aktive og passive ledstillingsevnetests.
Før bevægelsen påbegyndes, vil ekstremiteten blive bevæget ti gange for at forberede bevægelsen.
"Physio Master" telefonapplikationen vil blive brugt til at måle vinkelforskellen mellem det påvirkede og upåvirkede knæ ved bevægelsens slutpunkt.
Mens personen sidder oprejst med lige ryg og knæ bøjet i 90 grader, vil deltagerens knæ blive bøjet til 45 grader, og deltageren vil blive bedt om at gentage den samme vinkel med lukkede øjne.
Fejlen i vinkler (°) vil blive beregnet.
Passiv stillingssans vil blive målt og registreret ved passivt at bevæge deltageren til den bestemte vinkel (15-30-45-60) og derefter bede dem om at estimere vinklen, når de vender tilbage til udgangspositionen.
Gentaget fleksion og ekstension vil blive udført for at vurdere eventuelle fejl i bevægelsen.
Placeboøvelser vil også blive administreret under vurderingen.
Testen blev gentaget t
Berg Balance-skalaen blev udviklet primært til at vurdere postural kontrol og er bredt anvendt i mange rehabiliteringsindstillinger.
De 14 punkter i skalaen vurderer forventet balance under almindelige daglige aktiviteter, herunder stående og statisk siddebalance, samt drejning, samle genstande op fra gulvet og overførsler.
Scoring foretages typisk på en 5-punkts skala, der vurderer om patienten kan udføre opgaven sikkert og uafhængigt i en bestemt tidsperiode.
En score på 0 gives, når patienten slet ikke kan udføre bevægelsen, og en score på 4 gives, når patienten fuldfører bevægelsen uafhængigt.
Den maksimale score er 56, hvor en score på 0-20 indikerer nedsat balance, 21-40 indikerer acceptabel balance og 41-56 indikerer god balance.
Udførelsen af skalaen tager cirka 10 til 20 minutter.
Den tyrkiske validitets- og pålidelighedsundersøgelse af skalaen blev udført af Şahin et al. i 2008 på slagtilfaldspatienter.
Den måler den tid, det tager for en patient at rejse sig fra en stol, gå 3 meter, vende om og sætte sig ned igen.
Testtiden blev registreret i sekunder.
Testen blev gentaget tre gange, og den gennemsnitlige tid blev registreret som en score.
Hvis nødvendigt, blev patienten tilladt at udføre testen ved hjælp af en ganghjælp.
Det er en objektiv klinisk måling, der bruges til at vurdere funktionel mobilitet, dynamisk balance og faldrisiko hos ældre mennesker.
Det er også vist at være en valid og pålidelig test hos patienter, der har haft et slagtilfælde.
Denne test bruges til at bestemme ganghastighed.
To til tre forsøg vil blive udført med både komfortabel og maksimal hastighed efter deres valg.
Deltagere vil blive instrueret til at gå med en "normal komfortabel hastighed" eller "så hurtigt som sikkert muligt".
Der vil ikke blive udført øvelsesforsøg, og deltagerne vil hvile i mindst 30 sekunder mellem forsøgene.
Typiske sko, standard ortopædiske hjælpemidler og eventuelle nødvendige assistive enheder vil blive båret.
Deltagere vil gå cirka 14 meter, inklusive en 2-meters accelerations- og decelerationszone.
Tiden deltagerne bruger på at gå de midterste 6 meter af denne gangsti vil blive målt med et stopur, fra det øjeblik deres tæer først passerer startkeglen til det øjeblik de først passerer målkeglen.
Ganghastigheden vil blive beregnet for hvert forsøg.
Livskvalitet er også en vigtig prognostisk indikator for slagtilfælde og giver en bredere definition af sygdommen.
Denne skala består af 49 emner i 12 domæner: mobilitet, energi, øvre ekstremitetsfunktionalitet, arbejde/produktivitet, humør, egenomsorg, sociale roller, familieroller, syn, sprog, tænkning og personlighed.
SS-QOL-emner vurderes på en fempunkts Likert-type skala.
Svar spænder fra 1 (Meget uenig) til 5 (Meget enig).
Høje score på skalaen indikerer høj livskvalitet, mens lave score indikerer lav livskvalitet.
|
|
Eksperimentel: Kinesiotaping-gruppe (KB)
Kinesiotape vil blive anvendt for at øge den proprioceptive bevidsthed om knæleddet.
Tape vil blive anvendt ved hjælp af *"Y"-teknikken og *"I"-teknikken med fokus på medial og lateral støtte.
Kinesiotapen vil sidde på i 3 dage, efterfulgt af en pause på 1 dag, hvorefter den påføres igen.
Tapeændringer vil blive udført af en fysioterapeut i alt 8 uger.
|
Ledstillingsevnen vil blive vurderet ved hjælp af aktive og passive ledstillingsevnetests.
Før bevægelsen påbegyndes, vil ekstremiteten blive bevæget ti gange for at forberede bevægelsen.
"Physio Master" telefonapplikationen vil blive brugt til at måle vinkelforskellen mellem det påvirkede og upåvirkede knæ ved bevægelsens slutpunkt.
Mens personen sidder oprejst med lige ryg og knæ bøjet i 90 grader, vil deltagerens knæ blive bøjet til 45 grader, og deltageren vil blive bedt om at gentage den samme vinkel med lukkede øjne.
Fejlen i vinkler (°) vil blive beregnet.
Passiv stillingssans vil blive målt og registreret ved passivt at bevæge deltageren til den bestemte vinkel (15-30-45-60) og derefter bede dem om at estimere vinklen, når de vender tilbage til udgangspositionen.
Gentaget fleksion og ekstension vil blive udført for at vurdere eventuelle fejl i bevægelsen.
Placeboøvelser vil også blive administreret under vurderingen.
Testen blev gentaget t
Berg Balance-skalaen blev udviklet primært til at vurdere postural kontrol og er bredt anvendt i mange rehabiliteringsindstillinger.
De 14 punkter i skalaen vurderer forventet balance under almindelige daglige aktiviteter, herunder stående og statisk siddebalance, samt drejning, samle genstande op fra gulvet og overførsler.
Scoring foretages typisk på en 5-punkts skala, der vurderer om patienten kan udføre opgaven sikkert og uafhængigt i en bestemt tidsperiode.
En score på 0 gives, når patienten slet ikke kan udføre bevægelsen, og en score på 4 gives, når patienten fuldfører bevægelsen uafhængigt.
Den maksimale score er 56, hvor en score på 0-20 indikerer nedsat balance, 21-40 indikerer acceptabel balance og 41-56 indikerer god balance.
Udførelsen af skalaen tager cirka 10 til 20 minutter.
Den tyrkiske validitets- og pålidelighedsundersøgelse af skalaen blev udført af Şahin et al. i 2008 på slagtilfaldspatienter.
Den måler den tid, det tager for en patient at rejse sig fra en stol, gå 3 meter, vende om og sætte sig ned igen.
Testtiden blev registreret i sekunder.
Testen blev gentaget tre gange, og den gennemsnitlige tid blev registreret som en score.
Hvis nødvendigt, blev patienten tilladt at udføre testen ved hjælp af en ganghjælp.
Det er en objektiv klinisk måling, der bruges til at vurdere funktionel mobilitet, dynamisk balance og faldrisiko hos ældre mennesker.
Det er også vist at være en valid og pålidelig test hos patienter, der har haft et slagtilfælde.
Denne test bruges til at bestemme ganghastighed.
To til tre forsøg vil blive udført med både komfortabel og maksimal hastighed efter deres valg.
Deltagere vil blive instrueret til at gå med en "normal komfortabel hastighed" eller "så hurtigt som sikkert muligt".
Der vil ikke blive udført øvelsesforsøg, og deltagerne vil hvile i mindst 30 sekunder mellem forsøgene.
Typiske sko, standard ortopædiske hjælpemidler og eventuelle nødvendige assistive enheder vil blive båret.
Deltagere vil gå cirka 14 meter, inklusive en 2-meters accelerations- og decelerationszone.
Tiden deltagerne bruger på at gå de midterste 6 meter af denne gangsti vil blive målt med et stopur, fra det øjeblik deres tæer først passerer startkeglen til det øjeblik de først passerer målkeglen.
Ganghastigheden vil blive beregnet for hvert forsøg.
Livskvalitet er også en vigtig prognostisk indikator for slagtilfælde og giver en bredere definition af sygdommen.
Denne skala består af 49 emner i 12 domæner: mobilitet, energi, øvre ekstremitetsfunktionalitet, arbejde/produktivitet, humør, egenomsorg, sociale roller, familieroller, syn, sprog, tænkning og personlighed.
SS-QOL-emner vurderes på en fempunkts Likert-type skala.
Svar spænder fra 1 (Meget uenig) til 5 (Meget enig).
Høje score på skalaen indikerer høj livskvalitet, mens lave score indikerer lav livskvalitet.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Måling af knæleds positionssans
Tidsramme: 2 måneder
|
Kneledspositionssans vil blive evalueret ved hjælp af aktive og passive ledpositionssansprøver. Før testen vil lemmet blive passivt bevæget 10 gange for at forberede bevægelsen. Physiomaster-mobilapplikationen vil blive brugt til at måle den vinkelmæssige forskel mellem det påvirkede og det upåvirkede knæ i slutningen af bevægelsen. Aktiv ledpositionssans vil blive målt ved at bede deltagerne om at gentage en 45° knæfleksionsvinkel med lukkede øjne. Den vinkelmæssige fejl vil blive beregnet. Passiv ledpositionssans vil blive vurderet ved passivt at positionere knæet, og derefter bede deltagerne om at estimere vinklen efter at være vendt tilbage til udgangspositionen. Gentagne fleksions- og extensionsbevægelser vil blive udført, og fejlopdagelse vil blive registreret. Placebobevægelser vil blive inkluderet i evalueringen. |
2 måneder
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Berg Balance Scale (BBS)
Tidsramme: 2 måneder
|
Berg Balance Scale (BBS) bruges til at vurdere individers statiske og dynamiske balance. Den består af 14 punkter, der evaluerer evnen til at opretholde balancen under forskellige positioner, posturale ændringer og bevægelser. Vurderingen er baseret på individets evne til at udføre hver opgave enten selvstændigt eller inden for en bestemt tid eller afstand. Hvert punkt gives en score fra 0 til 4, hvor 0 angiver manglende evne til at udføre opgaven, og 4 afspejler normal præstation. Den maksimale totalscore er 56.
|
2 måneder
|
|
Timed Up and Go Test (TUG)
Tidsramme: 2 måneder
|
Timed Up and Go-testen (TUG) bruges til at vurdere funktionel mobilitet.
I TUG-testen måles den tid, det tager for deltageren at rejse sig fra en stol, gå 3 meter, vende om, gå tilbage og sætte sig ned igen.
|
2 måneder
|
|
10-Meter Gangtest (10MWT)
Tidsramme: 2 måneder
|
10-Meter Gå-testen (10MWT) bruges til at bestemme ganghastighed. Deltagerne vil udføre 2-3 forsøg både ved deres selvvalgte behagelige hastighed og maksimale sikre hastighed. Instruktionerne vil være at gå enten i et "normalt, behageligt tempo" eller "så hurtigt som muligt på en sikker måde." Der vil ikke blive gennemført øveforsøg, og deltagerne vil få mulighed for at hvile i mindst 30 sekunder mellem forsøg. Typisk fodtøj, sædvanlige orteser og nødvendige hjælpemidler vil blive brugt under testen. Deltagerne vil gå cirka 14 meter, hvilket inkluderer en 2-meters accelerationszone, en 6-meters tidsmålt midterafsnit og en 2-meters decelerationszone. Tiden for at gå de midterste 6 meter vil blive registreret med et stopur, startende når deltagerens tå passerer startkeglen og stoppende når tåen passerer slutkeglen. Ganghastigheden vil blive beregnet for hvert forsøg. |
2 måneder
|
|
Stroke-Specifik Livskvalitetsskala (SS-QOL)
Tidsramme: 2 måneder
|
Livskvalitet er også en vigtig prognostisk indikator ved slagtilfælde og giver en bredere forståelse af sygdommen. Stroke-Specific Quality of Life Scale (SS-QOL) består af 49 elementer fordelt på 12 domæner: mobilitet, energi, funktion i overekstremiteter, arbejde/produktivitet, humør, egenomsorg, sociale roller, familieroller, syn, sprog, tænkning og personlighed. SS-QOL-elementerne vurderes ved hjælp af en 5-punkts Likert-skala, hvor svarene spænder fra 1 (Meget uenig) til 5 (Meget enig). Højere score på skalaen indikerer en bedre livskvalitet, mens lavere score afspejler en dårligere livskvalitet. |
2 måneder
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Dilanur Ö Özkaraoğlu, Doctor Physiotherapist, Medipol University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MU-SBF-FTR-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Patienter med kronisk slagtilfælde
-
Jules Bordet InstituteMacopharma; Belgian Hematological SocietyRekrutteringRefractory Chronic Graft Versus Host Disease (cGVHD)Belgien
-
Columbia AsiaAfsluttetPatient Compliance | Læge-patient forholdIndien
-
University of AarhusUkendtPatientengagement | Patient Empowerment | Patient Compliance
-
Peking Union Medical College HospitalAfsluttetPatient efter hjerteklapkirurgi | Patient med langvarig mekanisk ventilationKina
-
University of British ColumbiaAfsluttetMeddelelse | Tilfredshed | Læge-patient forhold | Sygeplejerske-patient relationerCanada
-
University of California, San DiegoPatient-Centered Outcomes Research Institute; University of Massachusetts... og andre samarbejdspartnereAfsluttetPatientengagement | Læge-patient forhold | Lægens rolle | Patient aktiveringForenede Stater
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science UniversityAfsluttet
-
University of Dublin, Trinity CollegeDublin Dental University HospitalRekrutteringOverholdelse, patientIrland
-
Centre Hospitalier le MansRekruttering
-
Fondazione Policlinico Universitario Agostino Gemelli...AfsluttetHjertekirurgisk patientItalien