Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease

Study Overview
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Brief Summary
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The primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease

Official Title
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Feasibility and Effectiveness of Virtual Reality and the Use of Body Weight Support Treadmill Training in Parkinson's Disease: an Explorative Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Virtual Reality
* Behavioral: Conventional Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: idiopathic Parkinson Disease diagnosis age under 80 years severity of disease rated 2 or 3 at Hoehn & Yahr scale Exclusion Criteria: impaired cognitive functioning: score less than 24 on the Mini Mental State Examination neurologic conditions in addition to Parkinson Disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol severe Levodopa dyskinesia pregnancy

Ages Eligible for Study
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Maximum Age: 80 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: Virtual reality<br>Xbox Kinect + treadmill training | Behavioral: Virtual Reality<br>* 12 sessions of 1 hour (30 min of virtual reality and 30 min of aerobic exercise with treadmill training): three times a week over four weeks<br>|
| Active Comparator: Conventional Therapy<br>Specific conventional training for Parkinson's Disease | Behavioral: Conventional Therapy<br>* 12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walking Test | The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary. | up to weeks 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | This is an assessment scale of ability to maintain balance, or statically or while performing functional movement, including 14 observable tasks common to everyday life measured on a 5 point ordinal scale. | weeks: 0,4, 16 | 
| Time Up and Go Test | Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch. | weeks: 0,4, 16 | 
| 10 meter walk test | Assesses walking speed in meters per second over a short duration | weeks: 0,4, 16 | 
| Unified Parkinson's Disease Rating Scale | It is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease across the longitudinal disease course and provide a clinical endpoint in therapy trials. | weeks: 0,4, 16 | 
| Postural sway (Center of pressure (COP) trajectories) | Center of pressure (COP) trajectories | weeks: 0,4, 16 | 
| Metabolic measurements by Near infrared spectroscopy | Near InfraRed Spectroscopy (NIRS) is a noninvasive, portable technique for ambulatory or remote monitoring of human motor-cortex oxygenation changes in response to motor tasks | weeks: 0,4, 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Mobility, Balance, Virtual Reality, treadmill training