Comparison of Training in Virtual Environment With and Without Physiotherapeutic Intervention in Chronic Stroke Patients

NCT03361241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-18

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No Physiotherapeutic Intervention

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.

OTHER

Physiotherapeutic Intervention

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.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Maria Elisa P Piemonte, PT, PhD · University of Sao Paulo

  • Mariana A Lourenço, PT,Ms Student · University of Sao Paulo

  • Tatiana P Oliveira, PT,PhD Student · University of Sao Paulo

  • Camila S Miranda, PT, MS · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-02
Primary Completion
2018-11-30
Completion
2019-12-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03361241 on ClinicalTrials.gov