Back to resultsUse of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality
Conventional
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Virtual reality, Balance, Falls
Eligibility Criteria
Inclusion Criteria:
- patients of both sexes with hemiparesis after stroke of 18 to 65 years.
Exclusion Criteria:
- less than 6 months of injury with sensory or perceptual deficit.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Reality Group
Conventional Group
Arm Description
Rehabilitation with virtual reality using games with balance training goal.
Conventional physiotherapy with exercises for balance training.
Outcomes
Primary Outcome Measures
Dynamic Gait Index (DGI)
Balance during gait in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
Secondary Outcome Measures
Number of Falls
falls in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02475083
Brief Title
Use of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke
Official Title
Therapeutic Effect of Virtual Reality in Patients After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pedreira, Érika, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to investigate the therapeutic effect of virtual reality associated with conventional physiotherapy on balance during gait and the occurrence of falls in patients after stroke.
Detailed Description
Randomized clinical trial conducted with patients of both sexes with hemiparesis after stroke of 18 to 65 years. They excluded those who had less than six months of injury, with sensory or perceptual deficit. Patients included were randomized into two groups, a treatment group, which conducted rehabilitation with virtual reality associated with conventional physical therapy and the control group that performed only conventional physiotherapy. Randomization was done by a computer program in blocks, by a third person, respecting the allocation concealment. After selection and randomization, patients were evaluated at baseline, when they were collected demographic and clinical data, investigated the occurrence of falls in the three months prior to evaluation and rated the balance in motion using the Dynamic Gait Index (DGI). Patients were followed for 20 physiotherapy sessions, visits twice a week for an hour each. The assessment of the balance and the investigation of the occurrence of falls were repeated at the end of treatment, which occurred on average three months after the start of the intervention, by the same examiner, who remained blind to the group that the patient belonged.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Virtual reality, Balance, Falls
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
Rehabilitation with virtual reality using games with balance training goal.
Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy with exercises for balance training.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.
Intervention Type
Other
Intervention Name(s)
Conventional
Intervention Description
Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.
Primary Outcome Measure Information:
Title
Dynamic Gait Index (DGI)
Description
Balance during gait in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
Time Frame
avarage 8 weeks
Secondary Outcome Measure Information:
Title
Number of Falls
Description
falls in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
Time Frame
avarage 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients of both sexes with hemiparesis after stroke of 18 to 65 years.
Exclusion Criteria:
less than 6 months of injury with sensory or perceptual deficit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Fonseca
Organizational Affiliation
Pedreira, Érika, M.D.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Use of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke
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