Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment

Study Overview
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Brief Summary
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The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the balance, functionality and cognition of patients with Parkinson´s disease. It was a prospective, single blinded, randomized clinical trial performed at Brazil Parkinson Association and Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages 1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and experimental group, 16 each one. The study was finished at december 2011.

Detailed Description
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The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the balance, functionality and cognition of patients with Parkinson´s disease. It was a prospective, single blinded, randomized clinical trial performed at Brazil Parkinson Association and Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages 1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and experimental group, 16 each one. Both groups performed 14 training sessions, twice a week, for seven weeks. Each session was composed of a 30 minute-global-exercise series including stretching, muscle strengthen and axial mobility exercises. After this, both groups performed more 30 minutes of balance training: the control group performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit games which stimulated motor and cognitive functions. The main outcome measures were: (1) Unified Parkinson´s Disease Rating Scale (UPDRS); (2) Berg Balance Scale (BBS); (3) Unipedal Stance Test (UST) and (4) Montreal Cognitive Assessment (MoCA). The statistical analysis was done by repeated measures ANOVA in order to assess the possible differences among the analyzed variables. Both groups showed improvement in the section II of UPDRS, BBS, UST and MoCA. Patients with Parkinson´s disease showed balance and cognitive improvement with positive repercussion on daily living activities after 14 sessions of balance training without additional advantages to the virtual training.

Official Title
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Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment

Conditions
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Parkinson´s Disease

Intervention / Treatment
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* Device: Balance Training with Nintendo Wii Fit
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Parkinson´s disease both gender on stages 1 and 2,5 of Hoehn e Yahr Exclusion Criteria: depression cognitive impairment deficits of visual acuity Score on Berg Balance Scale under 46

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Training<br>The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit. | Device: Balance Training with Nintendo Wii Fit<br>* The participants of the study trained 10 balance games during 14 sessions.<br>|
| Active Comparator: Physical Therapy<br>The Control Group was trained by conventional Physical Therapy exercises. | Other: Physical Therapy<br>* Patients of the control group was trained with balance exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UNIFIED PARKINSON'S DISEASE RATING SCALE | The scale assesses the functional status of patients with parksinon´s disease, including the independency of daily activities, mood, secondary effects of medications and motor complications. | 08/2011 (up to 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Berg Balance Scale assesses the functional balance of patients with Parkinson´s disease. It is a clinic assessment of patient that evaluates the performance of patient to stand up and sit down, turn on and step, among others situations. | 08/2011 (up to 2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson´s disease, Postural Balance, virtual reality