Wearable Sensor-based Biofeedback Training for Balance and Gait in Parkinson's Disease: a Pilot Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Post-treatment score of Berg Balance Scale
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Mini-Mental State Examination <
- •Implanted deep brain stimulator.
Outcomes
Primary Outcomes
Post-treatment score of Berg Balance Scale
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
- Scores of Timed Up and Go test(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)