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Active, not recruitingNCT07304180Updated Feb 27, 2026

Exergame vs Balance Training in Hemiplegia

An interventional study of Exergaming and Balance exercise in Hemiplegia, Exergaming and Exercise, sponsored by Halic University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Halic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Hemiplegia
  • Exergaming
  • Exercise
  • Rehabilitation
03

In context

Hemiplegia

374 studies on the registry are indexed under Hemiplegia; 83 are open to participants now.

This study's enrollment of 30 is below the median of 34 across 310 interventional studies indexed under Hemiplegia.

Browse Hemiplegia studies →

Lead sponsor

Halic University is the lead sponsor of 80 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • 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

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    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.

    Other: Balance exercise

  • Experimental
    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.

    Other: Exergaming

Interventions

  • OtherExergaming

    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.

  • OtherBalance 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline and after 4 weeks

  2. 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)

    Time frame: Baseline and after 4 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and after 4 weeks

  2. 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.

    Time frame: Baseline and after 4 weeks

  3. 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.

    Time frame: Baseline and after 4 weeks

  4. 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.

    Time frame: Baseline and after 4 weeks

  5. 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.

    Time frame: Baseline and after 4 weeks

  6. 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.

    Time frame: Baseline and after 4 weeks

07

Study locations

1 site
  • Halic University
    Istanbul, Eyupsultan 2022, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07304180
Lead sponsor
Halic University
Responsible party
Ayşenur Çetinkaya (Lecturer (PhD), Halic University) — Principal investigator
First posted
Dec 26, 2025
Start date
Dec 16, 2025
Primary completion
Feb 15, 2026
Completion
Mar 15, 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

Ayşenur Çetinkaya
principal investigator · Halic University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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