NCT02786433

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 .

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

May 23, 2016

Last Update Submit

May 31, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

GROUP CONTROL

ACTIVE COMPARATOR

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

Other: conventional physiotherapy

EXPERIMENTAL GROUP

EXPERIMENTAL

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.

Other: Virtual Reality with X- Box Kinect®

Interventions

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pernambuco Parkinson Association

Recife, Pernambuco, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 1, 2016

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations