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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02786433
Other study ID # CAAE: 18732713.0.0000.5193
Secondary ID
Status Completed
Phase N/A
First received May 23, 2016
Last updated May 31, 2016
Start date February 2014

Study information

Verified date May 2016
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
conventional physiotherapy

Virtual Reality with X- Box Kinect®


Locations

Country Name City State
Brazil Pernambuco Parkinson Association Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 weeks No
Primary 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. 8 weeks No
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