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临床试验/NCT07304180
NCT07304180招募中不适用

Comparison of the Effects of Balance Exercises and Video Game-Based (Exergame) Exercises in Hemiplegia Rehabilitation

Halic University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月16日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Functional Reach Test

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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
  • Willing to voluntarily participate in the study.

排除标准

  • History of more than one stroke.
  • Participation in another exercise or rehabilitation program.
  • Body Mass Index greater than 29.
  • 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.

结局指标

主要结局

Functional Reach Test

时间窗: 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)

Berg Balance Scale

时间窗: 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)

次要结局

  • 10-Meter Walk Test(Baseline and after 4 weeks)
  • Fugl-Meyer Assessment for Lower Extremity(Baseline and after 4 weeks)
  • Timed Up and Go Test(Baseline and after 4 weeks)
  • Modified Barthel Index(Baseline and after 4 weeks)
  • Stroke Impact Scale(Baseline and after 4 weeks)
  • Falls Efficacy Scale-International(Baseline and after 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşenur Çetinkaya

Lecturer (PhD)

Halic University

研究点 (1)

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Exergame vs Balance Training in Hemiplegia | 临床试验