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

April 16, 2012
April 18, 2012
August 2009
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01580787 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment
Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Parkinson´s Disease
  • Device: Balance Training with Nintendo Wii Fit
    The participants of the study trained 10 balance games during 14 sessions.
  • Other: Physical Therapy
    Patients of the control group was trained with balance exercises.
  • Experimental: Virtual Reality Training
    The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.
    Intervention: Device: Balance Training with Nintendo Wii Fit
  • Active Comparator: Physical Therapy
    The Control Group was trained by conventional Physical Therapy exercises.
    Intervention: Other: Physical Therapy
Pompeu JE, Mendes FA, Silva KG, Lobo AM, Oliveira Tde P, Zomignani AP, Piemonte ME. Effect of Nintendo Wii™-based motor and cognitive training on activities of daily living in patients with Parkinson's disease: a randomised clinical trial. Physiotherapy. 2012 Sep;98(3):196-204. doi: 10.1016/j.physio.2012.06.004. Epub 2012 Jul 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
65 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01580787
saocamilo-sp
Yes
Jose Eduardo Pompeu, Sao Camilo University Center
Sao Camilo University Center
Not Provided
Principal Investigator: José E Pompeu, PhD Sao Camilo University Center
Sao Camilo University Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP