HemiplegiaNCT07304180
Exergame vs Balance Training in Hemiplegia
A study testing Exergaming and Balance exercise in people with Hemiplegia and Exergaming, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Hemiplegia rehabilitation is a long and demanding process, but with the right approach and patience, it is possible to regain lost functions and improve quality of life. Balance plays a critical role in helping stroke survivors regain independence. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Hemiplegia, Exergaming, Exercise
- What is being tested?
- Exergaming and Balance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 25 and 70 years.
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- History of more than one stroke.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Balance Exercises and Video Game-Based (Exergame) Exercises in Hemiplegia Rehabilitation
Hemiplegia rehabilitation is a long and demanding process, but with the right approach and patience, it is possible to regain lost functions and improve quality of life. Balance plays a critical role in helping stroke survivors regain independence. This randomized controlled study aims to compare the effects of balance exercises and video-based exergame training, in addition to conventional physiotherapy, on lower extremity functionality, balance, gait, daily living activities, quality of life, and fear of falling in patients with hemiplegia following stroke.
A minimum of 30 eligible participants will be randomly assigned to two groups:
Read more
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.
Read the detailed description
Hemiplegia rehabilitation is not only a process of regaining lost motor functions but also a journey toward restoring independence and self-confidence. Balance improvement is one of the key components of this process, as it directly influences gait, mobility, and daily life participation. With technological advancements, exergame-based interventions have emerged as engaging and motivating tools that can complement traditional rehabilitation programs.
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
- Hemiplegia, Exergaming, Exercise, Rehabilitation
- Being tested
- Exergaming, Balance exercise
- Medical subject headings
- Hemiplegia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1_Balance Exercise Group | Experimental | 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. Receives: Other: Balance exercise |
| Group 2_Exergame Group | Experimental | 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. Receives: Other: Exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
To assess postural control and fall risk. The scale consists of 14 items scored from 0 to 4, with a total possible score of 56. Higher scores indicate better balance ability. Assessments will be performed at baseline and after 4 weeks of intervention. Type: Continuous (Score range: 0-56)
Measured: Baseline and after 4 weeks
Functional Reach Test
To measure dynamic balance and the ability to maintain a stable base of support while reaching forward. The distance between the starting and ending hand positions is recorded in centimeters. Higher values indicate better balance and lower fall risk. Type: Continuous (Distance in cm)
Measured: Baseline and after 4 weeks
Secondary outcomes (6)
Fugl-Meyer Assessment for Lower Extremity
Evaluates motor function of the lower extremity, including reflex activity, movement within and outside synergies, and coordination/speed. The total score ranges from 0 to 34, with higher scores indicating better motor function.
Measured: Baseline and after 4 weeks
Timed Up and Go Test
Assesses functional mobility and dynamic balance. The time (in seconds) it takes to stand up from a chair, walk 3 meters, turn around, walk back, and sit down is recorded. Shorter times indicate better mobility.
Measured: Baseline and after 4 weeks
10-Meter Walk Test
Measures walking speed over a 10-meter distance. The average time (in seconds) of three trials is recorded. Faster times indicate better walking performance.
Measured: Baseline and after 4 weeks
Modified Barthel Index
Assesses independence in activities of daily living (e.g., feeding, dressing, mobility, toileting). Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: Baseline and after 4 weeks
Stroke Impact Scale
Evaluates quality of life after stroke across domains such as strength, hand function, mobility, daily activities, emotion, communication, participation, and memory. Scores range from 0 to 100, with higher values reflecting better perceived health status.
Measured: Baseline and after 4 weeks
Falls Efficacy Scale-International
Assesses fear of falling during daily activities. The 16-item questionnaire is scored from 16 to 64, with higher scores indicating greater fear of falling.
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start16 Dec 2025
- Primary completion15 Feb 2026
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Çetinkaya, Halic University
- Investigators
- Ayşenur Çetinkaya, Principal investigator, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304180
- Sponsor's protocol ID
- Acetinkaya008
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Balance Exercises and Video Game-Based (Exergame) Exercises in Hemiplegia Rehabilitation
- ClinicalTrials.gov ID
- NCT07304180
- Acronym / sponsor ID
- Acetinkaya008
- Conditions
- Hemiplegia, Exergaming, Exercise, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemiplegia rehabilitation is a long and demanding process, but with the right approach and patience, it is possible to regain lost functions and improve quality of life. Balance plays a critical role in helping stroke survivors regain independence. This randomized controlled study aims to compare the effects of balance exercises and video-based exergame training, in addition to conventional physiotherapy, on lower extremity functionality, balance, gait, daily living activities, quality of life, and fear of falling in patients with hemiplegia following stroke.
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
Hemiplegia rehabilitation is not only a process of regaining lost motor functions but also a journey toward restoring independence and self-confidence. Balance improvement is one of the key components of this process, as it directly influences gait, mobility, and daily life participation. With technological advancements, exergame-based interventions have emerged as engaging and motivating tools that can complement traditional rehabilitation programs.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1_Balance Exercise Group | Experimental | Other: Balance exerciseParticipants in this group will receive conventional physiotherapy combined with balance exercise sessions twice a week for four weeks under the supervision of a physiotherapist. |
| Group 2_Exergame Group | Experimental | Other: ExergamingParticipants 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged between 25 and 70 years.
- 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.
Key exclusion criteria (7 listed)
- History of more than one stroke.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergamingParticipants 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. | Other | Group 2_Exergame Group |
| Balance exerciseParticipants 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. | Other | Group 1_Balance Exercise Group |
Primary outcome
Berg Balance Scale
Time frame: Baseline and after 4 weeks
To assess postural control and fall risk. The scale consists of 14 items scored from 0 to 4, with a total possible score of 56. Higher scores indicate better balance ability. Assessments will be performed at baseline and after 4 weeks of intervention. Type: Continuous (Score range: 0-56)
Functional Reach Test
Time frame: Baseline and after 4 weeks
To measure dynamic balance and the ability to maintain a stable base of support while reaching forward. The distance between the starting and ending hand positions is recorded in centimeters. Higher values indicate better balance and lower fall risk. Type: Continuous (Distance in cm)
6 secondary outcomes
Fugl-Meyer Assessment for Lower Extremity
Time frame: Baseline and after 4 weeks
Timed Up and Go Test
Time frame: Baseline and after 4 weeks
10-Meter Walk Test
Time frame: Baseline and after 4 weeks
Modified Barthel Index
Time frame: Baseline and after 4 weeks
Stroke Impact Scale
Time frame: Baseline and after 4 weeks
Falls Efficacy Scale-International
Time frame: Baseline and after 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşenur Çetinkaya principal investigator
Halic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming and Balance exercise in people with Hemiplegia and Exergaming, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Baseline and after 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.