Biofeedback Rehabilitation in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Wearable Sensor-based Biofeedback Training for Balance and Gait in Parkinson's Disease: a Pilot Randomized Controlled Trial.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Gamepad system
* Other: Conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gamepad<br>Biofeedback rehabilitation with Gamepad system. | Device: Gamepad system<br>* Patients executed a set of tailored exercises including the control of weight-shift and body posture during static (e.g. upright sitting and standing), quasi-dynamic (e.g. sit-to-stand and gait initiation) and dynamic tasks (e.g. getting on a step, straight-line walking, walking with turns and over obstacles). Participants executed the tasks using Gamepad system which provided patients with visual and auditory feedback about their performances and assigned a score at the end of each exercise. The physiotherapist progressively adjusted training complexity by changing the reference values, including more difficult taks, changing the perceptive context, and/or including a dual-task.<br>|
| Active Comparator: Control<br>Conventional physiotherapy. | Other: Conventional physiotherapy<br>* A set of tailored exercises was defined by the clinical staff following current guidelines for physiotherapy in Parkinson's disease. In particular, stretching, joint mobilization, and balance and gait exercises were provided to participants, without any instrumentation producing biofeedback or external cues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment score of Berg Balance Scale | 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. | 7 weeks | 
| Post-treatment score of 10-meter Walk Test | 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. | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up score of Berg Balance Scale | Score of Berga Balance Scale assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure. | 11 weeks | 
| Follow-up score of 10-meter Walk Test | Score of 10-meter Walk Test assessed at the specified time frame, adjusted for baseline score through ANCOVA procedure. | 11 weeks | 
| Scores of Unified Parkinson's Disease Rating Scale - Motor examination (UPDRS-III) | Score of UPDRS-III assessed at the specified time frames, adjusted for baseline score through ANCOVA procedure. | 7 weeks and 11 weeks | 
| Scores of Timed Up and Go test | 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. | 7 weeks and 11 weeks | 
| Scores of Activities-specific Balance Confidence scale (ABC) | 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). | 7 weeks and 11 weeks | 
| Scores of Freezing Of Gait Questionnaire (FOGQ) | 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). | 7 weeks and 11 weeks | 
| Scores of Parkinson's Disease Questionnaire-39 (PDQ-39( | 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. | 7 weeks and 11 weeks | 
| Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT) | 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. | 7 weeks | 
| Amplitude of body sway in antero-posterior (Sway AP) and medio-lateral (Sway ML) directions | 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. | 7 weeks and 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Balance, Gait, Biofeedback