Biofeedback Rehabilitation in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Gamepad system; Other: Conventional physiotherapy

• Registration Number: NCT02713971
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-03
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-15
• Last Update Submitted: 2016-03-15
• Study First Posted: 2016-03-21
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Hoehn-Yahr stage 2 to 4.
• 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 < 24.
• Implanted deep brain stimulator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gamepad	Gamepad system	Biofeedback rehabilitation with Gamepad system.
Control	Conventional physiotherapy	Conventional physiotherapy.

Primary Outcome Measures

Name	Time	Method
Post-treatment score of Berg Balance Scale	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	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 Outcome Measures

Name	Time	Method
Follow-up score of Berg Balance Scale	11 weeks	Score of Berga Balance Scale assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure.
Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)	7 weeks	TSQ-WT consists in six areas (Benefit, Usability, Self-concept, Privacy and loss of control, Quality of life, and Wearing comfort) that evaluate the satisfaction of the subject with the wearable part of a system. Each area includes 5 statements rated by the user on a 5-pint Likert scale between 0 (strongly disagree with the statement) and 4 (strongly agree with the statement). In the present study, only Benefit, Usability and Wearing Comfort areas were administered. TSQ-WT was administered to the Gamepad Group only.
Scores of Activities-specific Balance Confidence scale (ABC)	7 weeks and 11 weeks	Score of ABC assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.; Activities-specific Balance Confidence scale is a questionnaire through which the subject rates his/her perceived level of confidence while performing 16 daily living activities. Scores range from 0% (not confident) to 100 % (completely confident).
Amplitude of body sway in antero-posterior (Sway AP) and medio-lateral (Sway ML) directions	7 weeks and 11 weeks	Sway AP and ML assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.; Subjects were tested for 30 seconds during upright standing on a stabilometric force platform in four sensory conditions: eyes open, eyes closed, eyes open with foam pads under feet, and eyes closed with foam pads under feet. Center of Pressure (CoP) sway in AP and ML directions was computed as the standard deviation of the time-course of AP and ML CoP displacements recorded by the platform.
Scores of Freezing Of Gait Questionnaire (FOGQ)	7 weeks and 11 weeks	Score of FOGQ assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.; Freezing Of Gait Questionnaire evaluates freezing severity with a 6-item interview. Each item is rated on a 5-point ordinal scale from 0 (absence of freezing) to 4 (severe freezing).
Scores of Parkinson's Disease Questionnaire-39 (PDQ-39(	7 weeks and 11 weeks	Score of PDQ-39 assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.; Parkinson's Disease Questionnaire-39 is a 39-item, self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life over the last month. Scores are from 0 to 100, with 100 representing maximum level of problems.
Follow-up score of 10-meter Walk Test	11 weeks	Score of 10-meter Walk Test assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure.
Scores of Unified Parkinson's Disease Rating Scale - Motor examination (UPDRS-III)	7 weeks and 11 weeks	Score of UPDRS-III assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.
Scores of Timed Up and Go test	7 weeks and 11 weeks	Score of Timed Up and Go test assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure.; Timed Up and Go test is a mobility test evaluating the time taken by the subject to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down.

Trial Locations

Locations (1)

Fondazione Don Gnocchi ONLUS; 🇮🇹 Milan, Italy