CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
No Physiotherapeutic Intervention +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03361241
NCT03361241N/ACompleted

Comparison of Effects of Training in a Virtual Environment With and Without Physiotherapeutic Intervention on the Motor Function, Postural Control and Gait in Chronic Stroke Patients : A Randomized Controlled Trial

University of Sao Paulo General Hospital·interventional·Posted Dec 4, 2017·Updated Feb 18, 2020

In Brief

A clinical study evaluating No Physiotherapeutic Intervention and Physiotherapeutic Intervention for Stroke. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The aim of this study is to compare the effects of balance training in a virtual environment with and without physiotherapeutic intervention on the motor function, balance and gait in chronic stroke patients. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 4, 2017
Enrollment StartApr 2, 2017
Primary CompletionNov 30, 2018
Study CompletionDec 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.6 years ago

Interventions

No Physiotherapeutic Interventionother

Experimental group will perform a balance training program in a virtual environment (using a gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) without verbal/manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the two attempts of the training no manual or verbal assistance will be provided. Physiotherapist participation during training will be restricted to ensuring patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game at the end of each attempt.

Physiotherapeutic Interventionother

Control group will perform a balance training program in a virtual environment (gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) with verbal and manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the first attempt of the training physiotherapist will provide manual and verbal assistance, providing corrections on movement (avoiding compensatory movements). In the second attempt, no manual or verbal assistance will be provided (only ensuring patient safety, providing motivational verbal stimuli), allowing the patient to organize his or her performance.