A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson

Study Overview
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Brief Summary
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The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.

Official Title
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Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study

Conditions
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Parkinson Disease, Gait Disorders, Neurologic

Intervention / Treatment
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* Other: Virtual reality combined with anti-gravity treadmill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having Parkinson's disease diagnosed by a neurological doctor. Having an alteration of the gait caused by the neurological disorder. Being able to have an independent and voluntary walk of 10 meters as minimum. Height more than 150 cm. Exclusion Criteria: Being blind. Medical contraindications for walking. Being amputee. Alcohol or drugs abuse. Other diseases that impedes the intervention.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Single-arm | Other: Virtual reality combined with anti-gravity treadmill<br>* The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system. The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gait autonomy | Changes in gait autonomy will be measured by 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the maximum distance (in meters) that the subject can walk during 6 minutes in a flat surface. | Baseline and 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gait speed | Changes in gait speed will be measured by 10-Meter Walk Test (10MWT). The 10MWT consists of asking the subject to walk a 14m distance on flat area and measure the time spent from meter 2 to meter 12. Time will be measured by a digital chronometer. Gait speed will be calculated in meter per second. | Baseline and 4-weeks | 
| Changes in balance and gait ability | Changes in balance and gait ability will be measured by Tinetti scale. The Tinetti test is a simple, reproducible way of assessing the risk of falling in the elderly. This scale is composed of two value, static and dynamic: the test grants a maximum of 16 points for static part (sitting) and 12 point for dynamic (walking) part. Higher is the score, better is the performance. | Baseline and 4-weeks | 
| Changes in quality of life | Changes in quality of life will be measured by by 36-Item Short-Form Health Survey (SF-36). SF-36 assesses 8 physical and mental health domains: 1) Physical Functioning, 2) Social Functioning, 3) Role-Physical, 4) Bodily Pain, 5) Mental Health), 6) Role-Emotional, 7) Vitality, and 8) General Health. For each scale, item scores are coded, summed, and transformed, with final values expressed as a percentage, ranging from 0 (worst health) to 100 (best health). | Baseline and 4-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson, Virtual reality, Anti-gravity treadmill, Rehabilitation, Gait disorders