Wearable Sensor-based Biofeedback Training for Balance and Gait in Parkinson's Disease: a Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Post-treatment score of Berg Balance Scale
研究概览
简要总结
Background: In this study, a new biofeedback system for balance and gait rehabilitation (Gamepad) was developed. The system, based on wearable inertial sensors, provides users with real-time visual and acoustic feedback about their movement during functional tasks. Gamepad was applied on subjects with Parkinson's disease (PD) in a pilot randomized controlled trial to investigate its feasibility and efficacy versus conventional physiotherapy. The investigators hypothesized that Gamepad system can be easily applied in clinical settings and that biofeedback training with Gamepad provides larger improvements of balance and gait in PD subjects, respect to conventional physiotherapy.
Methods: Forty-two PD patients underwent a 20-session training for balance and gait (45 minutes per session, 3 sessions per week). Participants were randomized into Gamepad Group (biofeedback rehabilitation with Gamepad system), and Control Group (conventional physiotherapy). Clinical and instrumental assessments were performed by a blind examiner pre-, post-intervention and at 1-month follow-up.
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)
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
- •Hoehn-Yahr stage 2 to
- •Ability to stand up more than 10 s and inability to stand on one foot more than 10 s.
- •Ability to walk for at least 6 m even with an assistive device.
- •Stable drug usage.
排除标准
- •Mini-Mental State Examination <
- •Implanted deep brain stimulator.
研究组 & 干预措施
Gamepad
Biofeedback rehabilitation with Gamepad system.
干预措施: Gamepad system (Device)
Control
Conventional physiotherapy.
干预措施: Conventional physiotherapy (Other)
结局指标
主要结局
Post-treatment score of Berg Balance Scale
时间窗: 7 weeks
Score of Berg Balance Scale assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure. Berg Balance Scale rates balance from 0 (cannot perform) to 4 (normal performance) on 14 items exploring the ability to sit, stand, lean, turn and maintain the upright position on one leg. Maximum score (i.e. 56 points) indicates unimpaired balance.
Post-treatment score of 10-meter Walk Test
时间窗: 7 weeks
Score of 10-meter Walk Test assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure. 10-meter Walk Test measures, with a stopwatch, the time (T) taken by the subject to walk between two lines at the distance of 10 meters. Walking speed is thus computed as 10/T (m/s). Both comfortable and fast gait speed can be measured. In the present study only comfortable gait speed was assessed.
次要结局
- Follow-up score of Berg Balance Scale(11 weeks)
- Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)(7 weeks)
- Scores of Activities-specific Balance Confidence scale (ABC)(7 weeks and 11 weeks)
- Amplitude of body sway in antero-posterior (Sway AP) and medio-lateral (Sway ML) directions(7 weeks and 11 weeks)
- Scores of Freezing Of Gait Questionnaire (FOGQ)(7 weeks and 11 weeks)
- Scores of Parkinson's Disease Questionnaire-39 (PDQ-39((7 weeks and 11 weeks)
- Follow-up score of 10-meter Walk Test(11 weeks)
- Scores of Unified Parkinson's Disease Rating Scale - Motor examination (UPDRS-III)(7 weeks and 11 weeks)
- Scores of Timed Up and Go test(7 weeks and 11 weeks)