Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Unified Parkinson's disease rating scale (UPDRS) part III
研究概览
简要总结
Virtual-reality-based interactive treadmill system will be applied to the Parkinsons' disease patients who can walk (Hoehn and Yahr stage 2 to 4). Subjects will be randomly allocated to either VR-based treadmill training group or treadmill training without VR-based interaction. The training will be provided for 3 sessions (30min/session)/week for 4weeks, the total of 12 sessions. The outcomes will be measured at baseline, immediately after the completion of the intervention and 1 month after the intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite or probable idiopathic Parkinson disease patient
- •age from 18 to 80 years old
- •H&Y stage 2 to 4 and who can walk 10 meter independently regardless of the use of gait aids
排除标准
- •unstable medical conditions
- •cognitive impairments which interfere with participation in virtual-reality based training
- •hemispatial neglect, visual disturbance, apraxia
- •other pre-existing disease involving the central nervous system (e.g. stroke, brain tumor)
- •requiring the continuous manual assist with touch during the treadmill training
- •can not give a consent
研究组 & 干预措施
Virtual reality-based interactive treadmill training
In this group, the subjects will receive virtual reality (VR)-based interactive treadmill training. During the 30-min training session, VR based interaction and feedback will be provided; the foot location will be visualized in the VR screen (semi-immersive condition), the obstacles will be seen in the screen from which subjects has to avoid, gait speed will be visualized, slopes of the treadmill will be changed according to the slope changes in VR and distractors will be added. Dual tasks will also be provided. Subjects in this group will receive a 30min/session, 3 sessions/week for 4 weeks, the total of 12 sessions of VR-based training.
干预措施: Virtual reality-based interactive treadmill training (Device)
Treadmill training without VR-based interaction
The subjects in this group will receive the treadmill gait training. Virtual reality environment will be provided during the gait training but no feedback and interaction will be provided. Subjects in this group will receive a 30min/session, 3 sessions/week for 4 weeks, the total of 12 sessions of treadmill-based training.
干预措施: Treadmill training without VR-based interaction (Device)
结局指标
主要结局
Unified Parkinson's disease rating scale (UPDRS) part III
时间窗: Change from Baseline UPDRS III at 4 weeks
motor domain of UPDRS, range: 0 (best) -52 (worst)
次要结局
- 10 meter walk test (10MWT)(Change from Baseline 10MWT at 8 weeks)
- Berg balance scale (BBS)(Change from Baseline BBS at 8 weeks)
- Freezing of gait questionnaire(Change from Baseline Freezing of gait questionnaire at 8 weeks)
- Fear of falling(Change from Baseline fear of falling at 8 weeks)
- Gait parameters from gait analysis(Change from Baseline gait parameters at 8 weeks)
- Total number of falls during the recent 1 month(Change from Baseline total number of falls at 8 weeks)
- User satisfaction evaluation questionnaire(At 4weeks (after the completion of whole interventions))
- Unified Parkinson's disease rating scale (UPDRS) part III(Change from Baseline UPDRS III at 8 weeks)
- 10 meter walk test (10MWT)(Change from Baseline 10MWT at 4 weeks)
- Berg balance scale (BBS)(Change from Baseline BBS at 4 weeks)
- Freezing of gait questionnaire(Change from Baseline Freezing of gait questionnaire at 4 weeks)
- Fear of falling(Change from Baseline fear of falling at 4 weeks)
- Total number of falls during the recent 1 month(Change from Baseline total number of falls at 4 weeks)
- Gait parameters from gait analysis(Change from Baseline gait parameters at 4 weeks)
研究者
Won-Seok Kim
Assistant professor
Seoul National University Bundang Hospital