NCT03686462已完成不适用
Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 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
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)
- User satisfaction evaluation questionnaire(At 4weeks (after the completion of whole interventions))
- 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)
- Unified Parkinson's disease rating scale (UPDRS) part III(Change from Baseline UPDRS III 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)
研究者
Won-Seok Kim
Assistant professor
Seoul National University Bundang Hospital
研究点 (2)
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