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

NCT ID: NCT02475083

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Group

Rehabilitation with virtual reality using games with balance training goal.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: OTHER

Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.

Conventional

Intervention Type: OTHER

Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.

Conventional Group

Conventional physiotherapy with exercises for balance training.

Group Type: ACTIVE_COMPARATOR

Conventional

Intervention Type: OTHER

Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.

Interventions

Virtual Reality

Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.

Intervention Type: OTHER

Conventional

Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pedreira, Érika, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Érika Pedreira

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erika Fonseca

Role: PRINCIPAL_INVESTIGATOR

Pedreira, Érika, M.D.

Other Identifiers

EP-13-RV

Identifier Type: -

Identifier Source: org_study_id