Use of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke
June 15, 2015 updated by: Érika Pedreira, Pedreira, Érika, M.D.
Therapeutic Effect of Virtual Reality in Patients After Stroke
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Group
Rehabilitation with virtual reality using games with balance training goal.
|
Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.
Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.
|
|
Active Comparator: Conventional Group
Conventional physiotherapy with exercises for balance training.
|
Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Gait Index (DGI)
Time Frame: avarage 8 weeks
|
Balance during gait in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
|
avarage 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Falls
Time Frame: avarage 8 weeks
|
falls in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
|
avarage 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erika Fonseca, Pedreira, Érika, M.D.
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
January 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
June 12, 2015
First Submitted That Met QC Criteria
June 15, 2015
First Posted (Estimate)
June 18, 2015
Study Record Updates
Last Update Posted (Estimate)
June 18, 2015
Last Update Submitted That Met QC Criteria
June 15, 2015
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EP-13-RV
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.