Exergame vs Balance Training in Hemiplegia

NCT07304180 | Active Not Recruiting

• 1 other identifier: Acetinkaya008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemiplegia; Exergaming; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Baseline and after 4 weeks

Secondary Outcomes (6)

• Fugl-Meyer Assessment for Lower Extremity

  Baseline and after 4 weeks

• Timed Up and Go Test

  Baseline and after 4 weeks

• 10-Meter Walk Test

  Baseline and after 4 weeks

• Modified Barthel Index

  Baseline and after 4 weeks

• Stroke Impact Scale

  Baseline and after 4 weeks

Study Arms (2)

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.

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.

Other: Exergaming

Interventions

Exergaming OTHER

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.

Group 2_Exergame Group

Balance exercise OTHER

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 1_Balance Exercise Group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Halic University

Istanbul, Eyupsultan, 2022, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Motor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ayşenur Çetinkaya

  Halic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer (PhD)

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: December 16, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)