Effects of Virtual Reality-Based Balance Games on Gait, Balance, and Quality of Life in Patients With Post-Stroke Hemiplegia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Berg Balance Scale Score
研究概览
简要总结
This prospective single-blind randomized controlled trial enrolled 43 hemiplegic patients hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Participants were randomly assigned to a virtual reality (VR) group (n = 23), which received routine physical therapy combined with VR-based balance training, or a conventional therapy (CT) group (n = 20), which received routine physical therapy alone. Interventions were delivered under physiotherapist supervision over 20 sessions, with the VR group receiving an additional 12 sessions of VR-based balance exercises. Outcomes were assessed at baseline, immediately post-treatment, and at an eight-week follow-up, including measures of balance, mobility, functional independence, walking capacity, quality of life, and static balance using the Tecnobody PK252 isokinetic balance measurement system.
详细描述
The study included 43 hemiplegic patients who met the inclusion criteria and were hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Patients were randomized into two groups using a sealed-envelope method: 23 patients were assigned to the VR group, which received conventional therapy combined with virtual reality-based balance games, and 20 patients were assigned to the CT group, which received only conventional therapy. The VR group received routine physical therapy and rehabilitation once daily for a total of 20 sessions, in addition to virtual reality-based balance games applied three times a week for 20 minutes per session, totaling 12 sessions, all under the supervision of a physiotherapist. The CT group received only routine physical therapy and rehabilitation once daily for a total of 20 sessions, also under the supervision of a physiotherapist. All patients were evaluated before treatment, at the end of treatment, and eight weeks after the end of treatment using the Berg Balance Test (BBT), Functional Reach Test (FRT), Timed Up and Go Test (TUG), Five Times Sit-to-Stand Test (5xSST), Functional Independence Measure (FIM), Six-Minute Walk Test (6MWT), Stroke-Specific Quality of Life Scale(SS-QOL), and static balance measurements obtained via the Tecnobody PK252 isokinetic balance measurement system.
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 (Outcomes Assessor)
盲法说明
This study was a prospective, single-blind, randomized controlled trial. Patients were randomized into two groups. The physiotherapists delivering the interventions were blinded to group assignments to prevent performance bias. Participants were aware of their intervention, but outcome assessments were conducted in a blinded manner to minimize detection bias.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-75
- •Hemiplegic patients (ischemic/hemorrhagic) for 3-18 months
- •No severe cognitive impairment, able to respond to visual and auditory commands
- •Mini Mental Test (MMT) score of 24 or higher
- •Ability to sit or stand independently
- •Berg Balance Test (BBT) score of at least 21-56 points (patient group with moderate and/or low risk of falls)
- •Brunnstrom 1-2-3 (for paretic upper extremity)
- •No history of non-paretic upper extremity fracture or amputation
- •No condition that prevents exercise
- •Individuals weighing less than 110 kg
- •Each patient must be successful in at least 1 round in each game
排除标准
- •Refusal to participate in the study or wishing to withdraw from the study
- •Having communication problems such as speech and language problems
- •Having advanced visual, vestibular or metabolic disorders that cause balance disorders
- •Having other neurological diseases that cause gait disorders (Parkinson's, Multiple Sclerosis, Neuromuscular Diseases, Myelomalacia, etc.)
研究组 & 干预措施
CT Group
Participants receive routine physical therapy only.
干预措施: Routine Physical Therapy (Behavioral)
VR Group
Participants receive routine physical therapy plus VR-based balance training.
干预措施: VR-Based Balance Training (Device)
结局指标
主要结局
Berg Balance Scale Score
时间窗: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Balance performance assessed using the Berg Balance Scale, which includes 14 functional tasks scored from 0 to 4 with a total score ranging from 0 to 56. Higher scores indicate better balance.
次要结局
- Functional Reach Test Distance(Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment)
- Timed Up and Go Test Time(Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment)
- Five Times Sit-to-Stand Test Time(Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment)
- Functional Independence Measure Total Score (FIM)(Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment)
- Six-Minute Walk Test Distance (6MWT)(Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment)
- Static Balance Score (Tecnobody PK252 Isokinetic Balance Measurement System)(Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment)
- Stroke-Specific Quality of Life Scale Score (SS-QOL)(Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment)
研究者
Merve Önoğul Özmen
Consultant
Gaziantep City Hospital