Effectiveness of Nintendo Switch Combined With Occupational Therapy to Reduce Fall Risk in Patients With Hemiparesis After Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fall Risk (Tinetti Scale)
研究概览
简要总结
Title: Effectiveness of Mixed Reality Combined with Occupational Therapy to Reduce Fall Risk in Patients with Hemiparesis After Acquired Brain Injury Study Purpose: This study aims to test whether adding Nintendo Switch video game exercises to regular occupational therapy helps adults with hemipareasia after brain injury. The main goals are to reduce fall risk, improve balance, and enhace quality of life and motivation during rehabilitation.
Study Design: This is a pilot randomized controlled trial. The study will run for 5 months at Polibea Norte Rehabilitation Center for Brain Injury in Madrid, Spain.
Participants: Adults over 18 years old with hemiparesia from stroke or brain injury who can walk and have mild to moderate balance problems.
Groups: Participants will be randomly assigned to one of two groups:
Control Group: Receives usual occupational therapy (2 sessions per week, 1 hour each) Experimental Group: Receives 30 minutes of occupational therapy plus 30 minutes of Nintendo Switch exercises (2 sessions per week, 1 hour total) for 8 weeks The Nintendo Switch sessions use Ring Fit Adventure and Nintendo Switch Sports games that require standing, balancing, reaching, and moving different body parts. A therapist supervises all sessions.
Before and after the 8-week intervention, all participants will be assessed on:
Fall risk and balance: Using standardized tests including the Tinetti Scale, Timed Up and Go test, and Functional Reach Test Functional independence: Using the Functional Independence Measure (FIM) Quality of life: Using the WHOQOL-BREF questionnaire Satisfaction with treatment: Using the Client Satisfaction Questionnaire (CSQ-8) This study will provide preliminary information about whether Nintendo Switch can be a useful tool for rehabilitation of adults with hemiparesia after brain injury. If the intervention proves feasible and shows positive effects, it could be developed into a larger study and potentially used in clinical practice as a complement to traditional therapy. The engaging nature of video games might improve motivation and adherence to rehabilitation, which are important factors for recovery.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals older than 18 years of age
- •Present hemiparesia as a consequence of acquired brain injury with clinical evidence of persistent motor deficit
- •Regularly attend rehabilitation treatment at Polibea Norte
- •Have ability to walk with or without technical aids
- •Present score between 14 and 22 on the Mini-BESTest test
- •Have ability to understand simple instructions and follow the intervention
- •Voluntarily accept participation and sign informed consent
排除标准
- •Present severe cognitive deficit or global aphasia preventing understanding of tasks and risks of the intervention
- •Present uncontrolled convulsive episodes or severe visual impairment preventing intervention with visual devices
- •Present vestibular disorders
- •Participating in other similar intervention programs during the same period
- •Not accepting voluntary participation in the study and/or not signing informed consent
结局指标
主要结局
Fall Risk (Tinetti Scale)
时间窗: Baseline (pre-intervention) and after 8 weeks (post-intervention, up to 1 week)
The Tinetti Scale assesses balance and gait to estimate fall risk. Includes two sections: balance (maximum 16 points) and gait (maximum 12 points), totaling 28 points. Higher score indicates lower fall risk. Administered through direct observation.
次要结局
- Gait Speed and Balance (Timed Up and Go Test - TUG)(Baseline (pre-intervention) and post-intervention (up to 1 week))
- Dynamic Balance (Functional Reach Test - FRT)(Baseline (pre-intervention) and post-intervention (up to 1 week))
- Functional Independence (Functional Independence Measure - FIM)(Baseline (pre-intervention) and post-intervention (up to 1 week))
- Quality of Life (WHOQOL-BREF)(Baseline (pre-intervention) and post-intervention (up to 1 week))
- Treatment Satisfaction (Client Satisfaction Questionnaire - CSQ-8)(Post-intervention (up to 1 week)])
研究者
Marta Gil Manglano
Occupational Therapist
Universidad Rey Juan Carlos