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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose Eduardo Pompeu, Sao Camilo University Center
ClinicalTrials.gov Identifier:
NCT01580787
First received: April 16, 2012
Last updated: April 18, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


Further study details as provided by Sao Camilo University Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580787

Sponsors and Collaborators
Sao Camilo University Center
Investigators
Principal Investigator: José E Pompeu, PhD Sao Camilo University Center
  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 August 26, 2014