- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07631182
Action Observation Therapy in Chronic Stroke Via Telerehabilitation
Investigation of the Effect of Action Observation Therapy Via Telerehabilitation Method on Upper Extremity Functions, Daily Living Activities and Quality of Life in Chronic Stroke Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Stroke is defined as a neurological condition caused by focal damage to the central nervous system due to vascular problems such as cerebral infarction, intracerebral or subarachnoid hemorrhage. Stroke is among the leading causes of death and disability worldwide.
Functional impairment in the upper extremities is frequently observed in stroke patients, significantly limiting their grasping and releasing functions, and consequently their daily living activities (ADL) such as eating, drinking, dressing, and self-care. Due to these limitations, stroke patients become dependent to varying degrees, negatively impacting their quality of life. Scientists are conducting various studies to find effective, low-cost, and easily applicable methods that can reduce the effects of stroke, which imposes a significant economic, physical, social, and psychological burden on patients and their families, and improve recovery.
Action Observation Therapy (AOT), which involves observing simple actions frequently used in ADL and then imitating those observed actions, is a rehabilitation approach applied in clinical settings in recent years to improve upper extremity function in the rehabilitation of stroke and various neurological diseases. The neural basis of AOT is the mirror neuron system, which is active not only when observing one's own movements but also when observing others' movements. Studies using Functional Magnetic Resonance Imaging have shown that mirror neuron activity increases when observing the movements of others. It is stated that observing an action and then trying to imitate it reduces interhemispheric inhibition, and as a result, it activates the primary motor cortex that causes the observed movement, facilitates the execution of the action, eliminates motor function disorders, and allows for the relearning of functions.
Telerehabilitation is the remote delivery of rehabilitation services through telecommunication technology. Telerehabilitation increases the accessibility of physiotherapy interventions in situations where face-to-face rehabilitation is not possible or difficult to access. In stroke patients with a lengthy rehabilitation process, telerehabilitation offers significant advantages, including reduced difficulties in transferring the patient to the healthcare center, shorter travel time, reduced transportation costs, and lower energy costs.
A literature review revealed no studies comparing the effects of AOT delivered via telerehabilitation on upper extremity function, hand skills, daily living activities, and quality of life in patients with chronic stroke compared with conventional physiotherapy.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mustafa KAVAK, Phd
- Telefonnummer: +905065089564
- E-mail: mustafakavak@karabuk.edu.tr
Studiesteder
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Merkez
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Karabük, Merkez, Tyrkiet (Türkiye), 78100
- Rekruttering
- Karabuk University
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Kontakt:
- Mustafa KAVAK
- Telefonnummer: 05065089564
- E-mail: mustafakavak@karabuk.edu.tr
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Karabük, Merkez, Tyrkiet (Türkiye), 78100
- Rekruttering
- Mustafa KAVAK
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Underforsker:
- Elif Ulukan, PT
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Kontakt:
- Mustafa KAVAK, Phd
- Telefonnummer: +905065089564
- E-mail: mustafakavak@karabuk.edu.tr
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Underforsker:
- Cihan Caner Aksoy, Assoc. Professor
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Underforsker:
- Musa Güneş, Phd
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Underforsker:
- İlker İlhanlı, Professor
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Being over 18 years of age,
- Diagnosis of left hemiparetic stroke,
- Having passed between 6 months since the onset of stroke,
- Being in stage 4 or 5 of the hand and stage 4, 5 or 6 of the upper extremity according to Brunnstrom staging,
- Being able to sit on a chair for 30 minutes without support (patients who scored 20 or more points in total from the Trunk Impairment Scale),
- Scoring 24 or more points from the Mini Mental Test
Exclusion Criteria:
- Unwillingness to participate in the study,
- Having spasticity that prevents grasping and releasing an object (levels 3 and 4 on the Modified Ashworth Scale),
- Having a contracture in any of the affected upper extremity joints,
- Having severe neglect disorder (scoring 21 or higher on the Catherine Bergego Scale),
- Having impaired cooperation, compliance, and behavior during the administration of tests used to obtain data,
- Having a mental impairment that prevents communication and following basic commands (scoring less than 24 on the Mini-Mental Test),
- Having additional neurological and/or orthopedic problems that may affect motor performance and sitting balance,
- Having severe visual and hearing problems (if any, these problems not corrected with assistive devices such as glasses, contact lenses, hearing aids, etc.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Action observation Therapy
Participants will receive AOT via telerehabilitation in addition to conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
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All participants will receive conventional physiotherapy, including stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic.
These traditional sessions will be administered by physiotherapists three times a week, each lasting 45 minutes.
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Ingen indgriben: control
Participants will receive only conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Spasticitet
Tidsramme: Baseline
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Spasticitet vil vurderes ved hjælp af den modificerede Ashworth -skala.
Når scoringen øges, øges spasticitet.
Den mindste score for denne skala er 1, og den maksimale score er 5.
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Baseline
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Fase af hemiplegi
Tidsramme: Baseline
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"Brunnstrom Hemiplegia Recovery iscenesættelse" vil blive brugt til at bestemme den hemiplegiske fase af patienterne.
Denne skala scores mellem 1 og 6.
Når scoringen stiger, forbedres patienten.
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Baseline
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Dominant side
Tidsramme: Baseline
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"Edinburgh -håndpræferencetesten" vil blive brugt til at bestemme den dominerende side, der bruges af patienten i dagligdagen.
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Baseline
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Cognitiff -funktion
Tidsramme: Baseline
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Mini mental test vil blive brugt til at evaluere kognitive funktioner.
I evalueringen indikerer 24-30 point, at kognitive funktioner er normale, 18-23 point indikerer mild kognitiv svækkelse, og 17 point og nedenfor indikerer, at kognitiv status påvirkes alvorligt.
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Baseline
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Forsømme
Tidsramme: Baseline
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Catherine Bergego -skalaen vil blive brugt til at vurdere virkningen af ensidig forsømmelse efter slagtilfælde på aktiviteter i dagligdagen.
1-10 angiver mild forsømmelse, 11-20 indikerer moderat forsømmelse, og 21-30 indikerer alvorlig forsømmelse.
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Baseline
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Motor function
Tidsramme: Baseline, five week later (after intervention)
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The "Fugl-Meyer Upper Extremity Motor Assessment Scale" will be used to evaluate upper extremity motor functions.
This scale ranges from 0 to 66 points.
As the score increases, motor function improves.
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Baseline, five week later (after intervention)
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Upper extremity function
Tidsramme: Baseline, five week later (after intervention)
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Evaluation of upper extremity functions (hand-arm) and motor speed will be done with the "Nine-Hole Peg Test".
Function decreases as the time spent for the test increases.
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Baseline, five week later (after intervention)
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Functional Independence
Tidsramme: Baseline, five week later (after intervention)
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Evaluation of upper extremity functions will be done with the "Nine-Hole Peg Test".
Function decreases as the time spent on the test increases.
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Baseline, five week later (after intervention)
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Life Quality
Tidsramme: Baseline, five week later (after intervention)
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The Stroke Specific Quality of Life Scale will be used to assess the quality of life of individuals with stroke.
The higher the total score, the better the quality of life of the individual with stroke.
This scale is scored between 49-245.As the score increases, the quality of life increases.
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Baseline, five week later (after intervention)
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Mancuso M, Tondo SD, Costantini E, Damora A, Sale P, Abbruzzese L. Action Observation Therapy for Upper Limb Recovery in Patients with Stroke: A Randomized Controlled Pilot Study. Brain Sci. 2021 Feb 26;11(3):290. doi: 10.3390/brainsci11030290.
- Shamili A, Hassani Mehraban A, Azad A, Raissi GR, Shati M. Effects of Meaningful Action Observation Therapy on Occupational Performance, Upper Limb Function, and Corticospinal Excitability Poststroke: A Double-Blind Randomized Control Trial. Neural Plast. 2022 Sep 16;2022:5284044. doi: 10.1155/2022/5284044. eCollection 2022.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
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
- Karabuk-02
Plan for individuelle deltagerdata (IPD)
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