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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
Sao Camilo University Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 16, 2012
    Last Updated
    April 18, 2012
    Sponsor
    Sao Camilo University Center
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    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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