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

Not Applicable

Completed

• Conditions: Parkinson´s Disease
• Interventions: Device: Balance Training with Nintendo Wii Fit; Other: Physical Therapy

• Registration Number: NCT01580787
• Lead Sponsor: Sao Camilo University Center

Brief Summary

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

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 Timeline

• Study Start: 2009-08
• Primary Completion: 2011-08
• Status Verified: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-18
• Last Update Submitted: 2012-04-18
• Study First Posted: 2012-04-19
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Training	Balance Training with Nintendo Wii Fit	The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.
Physical Therapy	Physical Therapy	The Control Group was trained by conventional Physical Therapy exercises.

Primary Outcome Measures

Name	Time	Method
UNIFIED PARKINSON'S DISEASE RATING SCALE	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.

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	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.