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

April 18, 2012 updated by: Jose Eduardo Pompeu, Sao Camilo University Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UNIFIED PARKINSON'S DISEASE RATING SCALE
Time Frame: 08/2011 (up to 2 years)
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
Time Frame: 08/2011 (up to 2 years)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sao Camilo University Center

Investigators

  • Principal Investigator: José E Pompeu, PhD, São Camilo University Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • saocamilo-sp

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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