Use of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Conventional; Other: Virtual Reality

• Registration Number: NCT02475083
• Lead Sponsor: Pedreira, Érika, M.D.

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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-15
• Last Update Submitted: 2015-06-15
• Study First Posted: 2015-06-18
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Group	Conventional	Conventional physiotherapy with exercises for balance training.
Virtual Reality Group	Virtual Reality	Rehabilitation with virtual reality using games with balance training goal.
Virtual Reality Group	Conventional	Rehabilitation with virtual reality using games with balance training goal.

Primary Outcome Measures

Name	Time	Method
Dynamic Gait Index (DGI)	avarage 8 weeks	Balance during gait in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.

Secondary Outcome Measures

Name	Time	Method
Number of Falls	avarage 8 weeks	falls in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.