- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07715526
Comparıson of vırtual realıty-Based walkıng and treadmıll exercıse Effects on Balance and Balance ın Chronic Stroke
Comparıson Of The Effects Of Vırtual Realıty-Based Walkıng Exercıse And Treadmıll Exercıse On Balance, Fear Of Fallıng, Motor And Respıratory Functıons, And Fatıgue In Patıents Wıth Chronıc Stroke
The aim of this study is to compare the effects of virtual reality-based walking exercises and treadmill walking exercises on balance, fear of falling, motor function, respiratory function, and fatigue in individuals who have had a stroke.
The main questions it aims to answer are:
How do virtual reality-based gait exercises and treadmill exercises affect balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke? H0: There is no statistically significant difference between virtual reality-based gait exercises and treadmill exercises in terms of their effects on balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke.
H1: There is a statistically significant difference between virtual reality-based gait exercises and treadmill exercises in terms of their effects on balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This research will be conducted to determine the degree of difference between virtual reality-based walking exercises and treadmill walking exercises in individuals who have had a stroke, when comparing their effects on balance, fear of falling, motor function, respiratory function, and fatigue.
In this study, the data collection process will begin after participants sign a voluntary consent form. Following consent, a structured sociodemographic data form will be completed using face-to-face interviews to determine the sociodemographic characteristics of the participants. This form will record information such as gender, age, height, and weight.
The Mini Mental State Test will be used to assess eligibility for inclusion in the study. The Mini Mental State Test is a widely used, quick, and standardized measurement tool for assessing individuals' cognitive levels. The test covers different cognitive domains such as attention, memory, orientation, compliance with verbal and written instructions, copying complex shapes, and spontaneous sentence writing. The highest possible score on the test is 30, and cognitive levels are classified as low, medium, or high based on the scores obtained. The Turkish adaptation of the test will be used in this study.
Participants' respiratory functions will be assessed using a spirometer and a Pulmonary Function Test. Measurements will be administered before and after treatment, both assessment times, by the same researcher. Tests will be conducted in accordance with internationally accepted criteria for admissibility and reproducibility, and the test will be repeated until at least three valid results are obtained for each measurement. Individual characteristics of participants, such as age, gender, height, and body weight, will be considered in the evaluation of measurement results. Respiratory parameters to be recorded will include: forced expiratory volume in the first second, forced vital capacity, the ratio between these two parameters, peak expiratory flow, mid-expiratory flow rate, maximum voluntary ventilation, and vital capacity values.
To assess respiratory muscle strength, maximum inspiratory pressure and maximum expiratory pressure measurements will be taken using an intraoral pressure measuring device. Measurements will be performed according to a standard measurement protocol. During maximum inspiratory pressure measurement, the participant will be in an upright seated position, a nasal clip will be used to prevent air passage through the nose, and the mouthpiece will be positioned to prevent air leakage. The participant will be asked to perform a maximum inspiration lasting at least 1.5 seconds after maximum expiration. The measurement will be repeated three times, and the highest value obtained will be recorded. Results will be expressed in centimeters of water pressure.
Similarly, for maximum expiratory pressure measurement, the participant will be in an upright seated position, a nose clip will be applied, and the mouthpiece will be properly positioned. The participant will be asked to perform a maximum expiration lasting at least 1.5 seconds after a maximum inspiration. The measurement will be performed three times, and the highest value will be recorded. Measurement results will be expressed in centimeters of water pressure.
The Timed Up and Walk Test will be used to assess participants' functional capacity. Before the test, participants will be given a detailed explanation of how the test will be administered. The participant will start in a seated position in a standard chair and walk to a marked point three meters away from the chair. After reaching the marked point, they will turn 180 degrees, return to the chair, and complete the test while seated. The stopwatch will be started the moment the participant gets up and stopped the moment they sit down again. The test will be administered three times, and the shortest time obtained will be evaluated.
The Functional Independence Scale will be used to assess functional independence. This scale is a comprehensive measurement tool that assesses the level of independence individuals can achieve in daily living activities. The scale consists of 18 items covering physical and cognitive functions. Physical functions include sub-areas of self-care, sphincter control, transference, and movement; while cognitive functions encompass communication and social-cognitive domains. Each item is scored between 1 and 7, with higher scores indicating a higher level of independence. The Turkish version of the scale will be used in this study.
The International Fall Activity Scale will be used to assess participants' levels of fear of falling. This scale consists of 16 items that question individuals' levels of anxiety regarding falls during daily living activities. Each item is evaluated using a four-point scoring system, with total scores ranging from 16 to 64. Higher scores indicate a higher level of fear of falling.
The Functional Ambulation Classification will be used to assess ambulation levels. This classification system rates individuals' walking levels on a scale of 0 to 5. Low scores indicate the absence of ambulation or dependence on external support, while high scores indicate that the individual can walk independently.
Walking speed will be assessed using the 10-Meter Walk Test. During the test, participants will be asked to walk from a designated starting point to a finish point at a normal walking speed. The distance covered and time elapsed will be recorded, and the walking speed will be calculated in meters per second.
The Fugl-Meyer Motor Assessment Scale will be used to assess motor functions. The scale has a rating system where each parameter is scored as unsuccessful, partially successful, or completely successful. Motor and sensory sections, which assess upper and lower extremity motor functions, will be used. Higher scores indicate better motor and sensory function levels. This scale is a valid and reliable measurement tool widely used in the assessment of paretic extremities in individuals who have experienced a stroke.
In this study, participants will be divided into intervention groups that include conventional physiotherapy along with different gait training approaches.
Conventional Physiotherapy Application
The conventional physiotherapy program will be applied for six weeks, five days a week. Each session will last thirty minutes. The treatment will include passive, active assistive, and active range of motion exercises for the lower extremities. Strengthening exercises to strengthen the muscle groups that aid in walking will be included in the program. Balance and coordination-focused exercises such as walking on different surfaces, obstacle course, and tandem walking will be applied to support balance development. Following the conventional physiotherapy application, electrical stimulation will be applied to the quadriceps and tibialis anterior muscles, which play a significant role in gait function, for fifteen minutes using an electrical stimulation device.
Virtual Reality-Based Gait Training Group
Participants in this group will receive virtual reality-based gait training in addition to conventional physiotherapy. The intervention will be conducted five days a week for six weeks, with each session lasting forty-five minutes. As part of the virtual reality application, participants will wear virtual reality glasses and perform walking exercises for fifteen minutes accompanied by three-dimensional video content simulating a nature walk.
Treadmill Walking Exercise Group
Participants in this group will receive treadmill walking exercises in addition to conventional physiotherapy. The intervention will last six weeks, five days a week, with each session lasting forty-five minutes. The walking speed on the treadmill will be determined individually based on the results of a ten-meter walk test administered at the beginning of the study. Participants will perform treadmill walking exercises for fifteen minutes at the determined speed.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Zeytinburnu
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Istanbul, Zeytinburnu, Turchia (Türkiye), 34275
- Istinye University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Chronic stroke patients with hemiparesis (stroke >6 months post-stroke).
- Ages 18-75.
- No visual, auditory, or communication problems.
- No additional neurological, cardiovascular, orthopedic, etc. conditions causing balance problems. Mini-Mental State Assessment (MMSE) score ≥24
- Functional Ambulation Classification (FAS) level 4-5
- Impaired pulmonary function (FEV1/FVC <70% with spirometry)
- Providing informed consent and being a volunteer
- Speaking and understanding Turkish.
Exclusion Criteria:
- Peripheral occlusive arterial disease
- Uncontrolled hypertension (≥190/110 mmHg)
- History of epilepsy
- Inability to respond to visual and sensory stimuli
- Orthopedic problems restricting movement in the lower extremities
- Having undergone any botulinum toxin application or surgery within the last 6 months
- Having neglect syndrome or speech disorders
- Vestibular system problems or use of medications that may affect the vestibular system
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Virtual Reality-Based Walking Exercise Group
Conventional physiotherapy + VR (virtual reality) Therapy / 45 min, 5 sessions per week / 6 weeks The patient will be shown a 3D video including a 15-minute nature walk while wearing virtual reality glasses.
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Conventional physiotherapy + VR Therapy / 45 min, 5 sessions per week / 6 weeks The patient will be shown a 3D video including a 15-minute nature walk while wearing virtual reality glasses.
|
|
Comparatore attivo: Treadmill Walking Exercise Group
Conventional physiotherapy + Treadmill / 45 min per week 5 sessions/6 weeks Walking speed will be calculated based on the 10-meter walking test performed at the beginning of the study; patients will then perform 15-minute walking exercises on the treadmill.
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Conventional physical therapy + Treadmill / 45 min per week 5 sessions/6 weeks Walking speed will be calculated based on a 10-meter walking test performed at the start of the study; patients will perform a 15-minute walking exercise on the treadmill.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Respiratory Outcome Measures - Volume (L)
Lasso di tempo: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
Respiratory parameters will be assessed at baseline and Week 6 using a COSMED PONY spirometer, with the best of three acceptable attempts recorded for each measure.
The primary spirometric outcomes in this category include FEV1 (L), FVC (L), and VC (L).
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FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
|
Respiratory Outcome Measures - Ratio (%)
Lasso di tempo: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
The FEV1/FVC ratio (%) will be recorded as a separate spirometric outcome.
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FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
|
Respiratory Outcome Measures - Flow Rate (L/min)
Lasso di tempo: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
Peak expiratory flow (PEF) and maximum voluntary ventilation (MVV) will be measured in L/min.
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FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
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Respiratory Outcome Measures - Flow Rate (L/s)
Lasso di tempo: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
Forced expiratory flow at 25-75% of the pulmonary volume (FEF 25-75%) will be measured in L/s.
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FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
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Respiratory Outcome Measures - Pressure (cmH₂O)
Lasso di tempo: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
Maximum inspiratory and expiratory pressures (MIP and MEP) will be measured using a pressure manometer with a nasal clip, with the highest of three attempts recorded in cmH₂O.
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FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
EVALUATION OF MOTOR FUNCTIONS
Lasso di tempo: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
Motor function will be assessed at baseline and Week 6 using the upper and lower extremity subscales of the Fugl-Meyer Motor Assessment Scale (FMA).
Each item is scored 0-2, with higher scores indicating better function.
The upper extremity subscale ranges from 0 to 66 points, and the lower extremity subscale ranges from 0 to 34 points.
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FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
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ASSESSMENT OF FEAR OF FALLING
Lasso di tempo: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
Assessed using the International Fall Activity Scale.
Consists of 16 items scored from 1 (no anxiety) to 4 (a lot of anxiety).
Total score ranges from 16 to 64, with higher scores indicating greater fear.
Measured on a scale (16-64 points).
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FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT
|
|
ASSESSMENT OF FUNCTIONAL INDEPENDENCE
Lasso di tempo: UNTIL THE END OF 6 WEEKS OF TREATMENT
|
Assessed using the Functional Independence Measure (total score).
Comprises 18 items (13 motor, 5 cognitive), each scored 1-7.
Total score ranges from 18 to 126, with higher scores indicating greater independence.
Measured on a scale (18-126 points).
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UNTIL THE END OF 6 WEEKS OF TREATMENT
|
|
EVALUATION OF FUNCTIONAL AMBULATION
Lasso di tempo: UNTIL THE END OF 6 WEEKS OF TREATMENT
|
Assessed using the Functional Ambulation Classification.
A 6-level ordinal scale ranging from 0 (non-ambulatory) to 5 (ambulatory).
Measured on a scale (0-5 points).
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UNTIL THE END OF 6 WEEKS OF TREATMENT
|
|
ASSESSMENT OF FUNCTIONAL CAPACITY
Lasso di tempo: UNTIL THE END OF 6 WEEKS OF TREATMENT
|
Assessed using the Timed Up and Go Test.
The participant rises from a chair, walks 3 meters, turns, returns, and sits down.
The test is administered three times, and the shortest time is recorded.
Measured in seconds (s).
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UNTIL THE END OF 6 WEEKS OF TREATMENT
|
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ASSESSMENT OF FATIGUE
Lasso di tempo: UNTIL THE END OF 6 WEEKS OF TREATMENT
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Assessed using the Modified Borg Category-Rate (CR10) Scale.
Participants rate their perceived exertion from 0 (no exertion) to 10 (maximum exertion).
Measured on a scale (0-10 points).
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UNTIL THE END OF 6 WEEKS OF TREATMENT
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gokay KUCUKYILMAZ, BSc, Istinye University
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Inizio studio (Effettivo)
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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Ultimo aggiornamento pubblicato (Effettivo)
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Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 25-127
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Descrizione del piano IPD
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