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

Stroke Clinical Trial

Official title:

Therapeutic Effect of Virtual Reality in Patients After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475083
• Other study ID #: EP-13-RV
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: June 15, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: Pedreira, Érika, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Virtual Reality
Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.
• Conventional
Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pedreira, Érika, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Gait Index (DGI)	Balance during gait in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.	avarage 8 weeks	Yes
Secondary	Number of Falls	falls in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.	avarage 8 weeks	Yes