Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment
Primary Purpose
Parkinson´s Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Balance Training with Nintendo Wii Fit
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson´s Disease focused on measuring Parkinson´s disease, Postural Balance, virtual reality
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Reality Training
Physical Therapy
Arm Description
The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.
The Control Group was trained by conventional Physical Therapy exercises.
Outcomes
Primary Outcome Measures
UNIFIED PARKINSON'S DISEASE RATING SCALE
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
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.
Full Information
NCT ID
NCT01580787
First Posted
April 16, 2012
Last Updated
April 18, 2012
Sponsor
Sao Camilo University Center
1. Study Identification
Unique Protocol Identification Number
NCT01580787
Brief Title
Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment
Official Title
Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sao Camilo University Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson´s Disease
Keywords
Parkinson´s disease, Postural Balance, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Training
Arm Type
Experimental
Arm Description
The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
The Control Group was trained by conventional Physical Therapy exercises.
Intervention Type
Device
Intervention Name(s)
Balance Training with Nintendo Wii Fit
Intervention Description
The participants of the study trained 10 balance games during 14 sessions.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
Patients of the control group was trained with balance exercises.
Primary Outcome Measure Information:
Title
UNIFIED PARKINSON'S DISEASE RATING SCALE
Description
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.
Time Frame
08/2011 (up to 2 years)
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
08/2011 (up to 2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José E Pompeu, PhD
Organizational Affiliation
Sao Camilo University Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22898575
Citation
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.
Results Reference
derived
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Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment
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