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Virtual Reality Effects on Functional Capacity and Quality of Life of People With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
conventional physiotherapy
Virtual Reality with X- Box Kinect®
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with clinical diagnosis of idiopathic Parkinson's disease
  • Male and female
  • Stage 1-3 of the Hoehn and Yahr scale.

Exclusion Criteria:

  • Have other neurological diseases
  • They have decompensated systemic diseases
  • Musculoskeletal changes that prevent the achievement of movements
  • With lowering of the cognitive level assessed using the MiniMental State examination with cutoff point according to education
  • With respiratory impairment
  • With medical restrictions for performing exercises
  • In physical therapy, occupational therapy service for 3 months or more;

Sites / Locations

  • Pernambuco Parkinson Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GROUP CONTROL

EXPERIMENTAL GROUP

Arm Description

Participants in the control group only underwent conventional physiotherapy. Conventional therapy includes stretching and strengthening exercises with cane aid, leggings , elastic band and overball for upper and lower limbs , in addition to gait and balance training. The intervention for the control group was applied for five weeks with sessions of 60 minutes twice a week

The subjects in the experimental group underwent conventional physiotherapy (The same applied in the control group) associated with virtual reality , performed with the console X -Box Kinect® of Microsoft. Durante the achievement of the virtual reality practice, Kinect and Kinect games Adventures® Dance® demanded the anterior movements players -posterior and lateral , as well as jumps and squats to get rid of the game obstacles. They Kinect Dance® game were all required movements of the previous game more dance . The intervention lasted five weeks , with two weekly sessions lasting 30 minutes to conventional therapy and 30 minutes to virtual reality.

Outcomes

Primary Outcome Measures

Unified Parkinson's Disease Rating Scale - Evaluates disease progression
Through the UPDRS disease progression was evaluated. Composed of 42 items, divided into four parts: mental activity, behavior and mood ; activities of daily living, motor operation and complications of drug therapy. For this study we evaluated the items : activities of daily living and motor examination on . The score for each item ranges from 0 to 4, and the maximum value indicates greater involvement by the disease and the minimum normality.
Parkinson's Disease Questionnaire (PDQ-39) - evaluates quality of life
The PDQ-39 is a method that evaluates the quality of life (QOL) in patients with PD through a questionnaire self-explanatory and easy to understand. There are 39 items divided into eight categories: mobility; activities of daily living; emotional well-being; social difficulties of PD; social support; cognition; communication and bodily discomfort. The score ranges from 0 (no problem) to 100 (maximum problem), or a low score indicates a better perception of quality of life.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2016
Last Updated
May 31, 2016
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02786433
Brief Title
Virtual Reality Effects on Functional Capacity and Quality of Life of People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

5. Study Description

Brief Summary
Introduction: Parkinson's disease (PD) is a progressive neurodegenerative disorder of dopaminergic neurons that can cause some mobility limitations and it has association with quality of life (QOL) in patients with PD. Virtual reality (VR) has been used to treat of these patients Objective: Evaluate the functional capacity and QOL of individuals with PD using VR with X-Box Kinect®. Methods: Were selected 20 individuals classified as stages 1-3, aged 50-75 years. They were divided by lot into two groups (control and experimental) with ten patients in each. The group (CG) treated with exercises (conventional therapy) during five-week, with two sessions per week lasting 60 minutes, while the experimental group (EG) spent half the time with conventional physical therapy and other half of time in virtual rehabilitation (VR). Subjects were evaluated before and after treatment using the following scales: Unified Parkinson's Disease Rating Scale and Parkinson's Disease Questionnaire .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP CONTROL
Arm Type
Active Comparator
Arm Description
Participants in the control group only underwent conventional physiotherapy. Conventional therapy includes stretching and strengthening exercises with cane aid, leggings , elastic band and overball for upper and lower limbs , in addition to gait and balance training. The intervention for the control group was applied for five weeks with sessions of 60 minutes twice a week
Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
The subjects in the experimental group underwent conventional physiotherapy (The same applied in the control group) associated with virtual reality , performed with the console X -Box Kinect® of Microsoft. Durante the achievement of the virtual reality practice, Kinect and Kinect games Adventures® Dance® demanded the anterior movements players -posterior and lateral , as well as jumps and squats to get rid of the game obstacles. They Kinect Dance® game were all required movements of the previous game more dance . The intervention lasted five weeks , with two weekly sessions lasting 30 minutes to conventional therapy and 30 minutes to virtual reality.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
Virtual Reality with X- Box Kinect®
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale - Evaluates disease progression
Description
Through the UPDRS disease progression was evaluated. Composed of 42 items, divided into four parts: mental activity, behavior and mood ; activities of daily living, motor operation and complications of drug therapy. For this study we evaluated the items : activities of daily living and motor examination on . The score for each item ranges from 0 to 4, and the maximum value indicates greater involvement by the disease and the minimum normality.
Time Frame
8 weeks
Title
Parkinson's Disease Questionnaire (PDQ-39) - evaluates quality of life
Description
The PDQ-39 is a method that evaluates the quality of life (QOL) in patients with PD through a questionnaire self-explanatory and easy to understand. There are 39 items divided into eight categories: mobility; activities of daily living; emotional well-being; social difficulties of PD; social support; cognition; communication and bodily discomfort. The score ranges from 0 (no problem) to 100 (maximum problem), or a low score indicates a better perception of quality of life.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with clinical diagnosis of idiopathic Parkinson's disease Male and female Stage 1-3 of the Hoehn and Yahr scale. Exclusion Criteria: Have other neurological diseases They have decompensated systemic diseases Musculoskeletal changes that prevent the achievement of movements With lowering of the cognitive level assessed using the MiniMental State examination with cutoff point according to education With respiratory impairment With medical restrictions for performing exercises In physical therapy, occupational therapy service for 3 months or more;
Facility Information:
Facility Name
Pernambuco Parkinson Association
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

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Virtual Reality Effects on Functional Capacity and Quality of Life of People With Parkinson's Disease

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