- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02786433
Virtual Reality Effects on Functional Capacity and Quality of Life of People With Parkinson's Disease
May 31, 2016 updated by: Douglas Monteiro da Silva, Universidade Federal de Pernambuco
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pernambuco
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Recife, Pernambuco, Brazil
- Pernambuco Parkinson Association
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: GROUP CONTROL
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 |
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EXPERIMENTAL: EXPERIMENTAL GROUP
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unified Parkinson's Disease Rating Scale - Evaluates disease progression
Time Frame: 8 weeks
|
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.
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8 weeks
|
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Parkinson's Disease Questionnaire (PDQ-39) - evaluates quality of life
Time Frame: 8 weeks
|
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.
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (ACTUAL)
April 1, 2014
Study Registration Dates
First Submitted
May 23, 2016
First Submitted That Met QC Criteria
May 31, 2016
First Posted (ESTIMATE)
June 1, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
June 1, 2016
Last Update Submitted That Met QC Criteria
May 31, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 18732713.0.0000.5193
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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