Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-15
2026-03-15
Brief Summary
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A minimum of 30 eligible participants will be randomly assigned to two groups:
Group 1 (Balance Exercise Group): Conventional physiotherapy plus balance exercises.
Group 2 (Exergame Group): Conventional physiotherapy plus video-based exergame sessions using the Nintendo Switch Ring Fit Adventure.
Both interventions will be conducted twice a week for four weeks under the supervision of a physiotherapist. Assessments will be performed before and after the intervention using standardized scales.
Detailed Description
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This study aims to compare the effectiveness of balance exercise training and exergame-based exercise programs when added to conventional physiotherapy in stroke patients with hemiplegia. Participants who meet the inclusion criteria and provide informed consent will be randomly allocated into two groups (n ≥ 15 per group).
Group 1 (Balance Exercise Group): Participants will perform balance exercises twice a week for four weeks, in addition to their conventional physiotherapy program, under the supervision of a physiotherapist.
Group 2 (Exergame Group): Participants will perform exergame sessions using Nintendo Switch Ring Fit Adventure twice a week for four weeks, alongside the same conventional physiotherapy program.
Outcome measures:
Lower extremity motor function: Fugl-Meyer Assessment for Lower Extremity Balance: Berg Balance Scale Functional mobility and gait: Functional Reach Test, Timed Up and Go Test, 10-Meter Walk Test Activities of daily living: Modified Barthel Index Quality of life: Stroke Impact Scale Fear of falling: Falls Efficacy Scale-International Assessments will be conducted at baseline and after the four-week intervention. Data analysis will be performed using the Statistical Package for Social Sciences (SPSS). Continuous variables will be expressed as mean ± standard deviation, and categorical variables as frequency and percentage. Depending on the normality of data distribution, appropriate parametric or non-parametric tests will be applied, with the level of significance set at p ≤ 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1_Balance Exercise Group
Participants in this group will receive conventional physiotherapy combined with balance exercise sessions twice a week for four weeks under the supervision of a physiotherapist.
Balance exercise
Participants in this group will perform balance exercise sessions in addition to conventional rehabilitation. These sessions will be conducted twice a week for four weeks, with each session lasting approximately 15-20 minutes.
Weeks 1-2: Weight shifting in parallel bars, marching in place within parallel bars, mini squats while holding the bars, tandem stance, and tandem and lateral walking in parallel bars.
Week 3: Controlled weight shifting outside the parallel bars, tandem stance, marching in place, mini squats against a wall, backward walking in parallel bars, obstacle course walking, and kicking a stationary ball with the non-affected foot.
Week 4: Picking up objects placed at different angles from a standing position, catching and throwing a ball, supported single-leg standing on the affected side, weight shifting on a balance board, kicking a moving ball with the non-affected foot, and obstacle walking tasks.
Group 2_Exergame Group
Participants in this group will perform video-based exergame sessions in addition to conventional rehabilitation. The exergame intervention will be conducted using the Nintendo Switch Ring Fit Adventure game. Sessions will take place twice a week for four weeks under the supervision of a physiotherapist.
Exergaming
Participants in this group will perform video-based exergame sessions in addition to conventional rehabilitation. These sessions will be conducted twice a week for four weeks, with each session lasting approximately 15-20 minutes under the supervision of a physiotherapist, using the Nintendo Switch Ring Fit Adventure game. The exergame program was designed by a specialist physiotherapist.
Interventions
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Exergaming
Participants in this group will perform video-based exergame sessions in addition to conventional rehabilitation. These sessions will be conducted twice a week for four weeks, with each session lasting approximately 15-20 minutes under the supervision of a physiotherapist, using the Nintendo Switch Ring Fit Adventure game. The exergame program was designed by a specialist physiotherapist.
Balance exercise
Participants in this group will perform balance exercise sessions in addition to conventional rehabilitation. These sessions will be conducted twice a week for four weeks, with each session lasting approximately 15-20 minutes.
Weeks 1-2: Weight shifting in parallel bars, marching in place within parallel bars, mini squats while holding the bars, tandem stance, and tandem and lateral walking in parallel bars.
Week 3: Controlled weight shifting outside the parallel bars, tandem stance, marching in place, mini squats against a wall, backward walking in parallel bars, obstacle course walking, and kicking a stationary ball with the non-affected foot.
Week 4: Picking up objects placed at different angles from a standing position, catching and throwing a ball, supported single-leg standing on the affected side, weight shifting on a balance board, kicking a moving ball with the non-affected foot, and obstacle walking tasks.
Eligibility Criteria
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Inclusion Criteria
* Have experienced either hemorrhagic or ischemic stroke.
* At least six months have passed since the stroke event.
* Have a Modified Rankin Scale score of 2 or 3.
* Able to stand independently.
* Able to walk at least 10 meters independently or with an assistive device.
* Able to sit and stand up independently.
* Have a Brunnstrom stage of at least 4 in both upper and lower extremities.
* Have a Brunnstrom stage of at least 3 in the hand.
* Have a Mini-Mental State Examination score greater than 24.
* Willing to voluntarily participate in the study.
Exclusion Criteria
* Participation in another exercise or rehabilitation program.
* Body Mass Index greater than 29.9.
* Cognitive, visual, or auditory impairments that interfere with -communication.
* Presence of other neurological disorders such as multiple sclerosis, Parkinson's disease, or spinal cord injury.
* Vestibular system disorders affecting balance (e.g., vertigo, CANVAS syndrome).
* Severe contractures, joint complications affecting movement, recent fractures, arthritis, or use of medications that may impair physical function.
25 Years
70 Years
ALL
No
Sponsors
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Halic University
OTHER
Responsible Party
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Ayşenur Çetinkaya
Lecturer (PhD)
Principal Investigators
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Ayşenur Çetinkaya
Role: PRINCIPAL_INVESTIGATOR
Halic University
Locations
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Halic University
Istanbul, Eyupsultan, Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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Acetinkaya008
Identifier Type: -
Identifier Source: org_study_id