Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson´s Disease |
Device: Balance Training with Nintendo Wii Fit Other: Physical Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment |
- UNIFIED PARKINSON'S DISEASE RATING SCALE [ Time Frame: 08/2011 (up to 2 years) ] [ Designated as safety issue: No ]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.
- Berg Balance Scale [ Time Frame: 08/2011 (up to 2 years) ] [ Designated as safety issue: No ]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.
| Enrollment: | 32 |
| Study Start Date: | August 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Virtual Reality Training
The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.
|
Device: Balance Training with Nintendo Wii Fit
The participants of the study trained 10 balance games during 14 sessions.
|
|
Active Comparator: Physical Therapy
The Control Group was trained by conventional Physical Therapy exercises.
|
Other: Physical Therapy
Patients of the control group was trained with balance exercises.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 65 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided by Sao Camilo University Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jose Eduardo Pompeu, Clinical Professor, Sao Camilo University Center |
| ClinicalTrials.gov Identifier: | NCT01580787 History of Changes |
| Other Study ID Numbers: | saocamilo-sp |
| Study First Received: | April 16, 2012 |
| Last Updated: | April 18, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Sao Camilo University Center:
|
Parkinson´s disease Postural Balance virtual reality |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 19, 2013