Virtual Rehabilitation and PNF in the Recovery of the Motor Function Post Stroke

March 31, 2018 updated by: Vítor Antônio dos Santos Júnior, Federal University of Bahia

Effectiveness of Virtual Rehabilitation and Proprioceptive Neuromuscular Facilitation in the Recovery of the Motor Function Post Stroke: A Randomized Clinical Trial

The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the recovery of the motor function of poststroke hemiparesis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomised clinical trial (RCT) will be held in following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials). This RCT have longitudinal and prospective feature, held at the Neurosciences Clinic located at the Clinic Professor Francisco Magalhães Neto the HUPES Complex / Federal University of Bahia from June 2015 until June 2016.

In the initial evaluation were obtained by a trained examiner and blinded to the allocation of participants, all personal data of all patients, as well as evaluations of balance and quality of life through specific validated scales:

1. Fugl Meyer scale (FMS);

The investigators employ an experimental program of therapeutic exercises for the PNF method and virtual rehabilitation with NW, for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • BA
      • Salvador, BA, Brazil, 40.110-060
        • Complex Hospital Professor Edgard Santos, Federal University of Bahia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18 and 80 years, of both sexes; neurological clinical diagnosis of stroke;
  • owning grade 2-4 spasticity according to the Ashworth scale;
  • hemiparetic patients after 6 months of onset of stroke;
  • deficit moderate gait according to Functional Ambulation Classification (values ≥ 2).

Exclusion Criteria:

  • score <24 on the Mini Mental State Examination;
  • other associated neurological diseases, as well as orthopedic and no visual or hearing impairment;
  • participation in other rehabilitation programs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Virtual Rehabilitation

A virtual rehabilitation program (G0) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.

The G0 treatment program consists of the following protocols: a) protocol 1 games (Balance Bubble Plus and Tennis); b) protocol 2 games (Rhythm Parade and Boxing).
Other: Virtual Rehabilitation
It is the use of the NW games for rehabilitation of balance in post-stroke patients.
Other Names:
  • NW Wii-rehabilitation Commercial Game
Experimental: PNF Method
A program of therapeutic exercises (G1) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The G1 treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation), and 10 minutes diagonal exercise scapula (anterior and posterior elevation); b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;
Other: PNF Method
It is the use of the therapeutic exercises based on the PNF diagonals for rehabilitation of balance in post-stroke patients.
Other Names:
  • Kabat method Diagonals of PNF
Active Comparator: Virtual Rehabilitation and PNF Method
In G2 program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.
Other: Virtual Rehabilitation and PNF Method
It is the use of the exercises based on the PNF diagonals and of the NW for rehabilitation of balance in post-stroke patients.
Other Names:
  • Kabat method Wii-rehabilitation Commercial Game Diagonals of PNF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke
Time Frame: 8 weeks
Fugl-Meyer Assessment
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Bahia

Investigators

  • Study Director: Ailton S Melo, PhD, Federal University of Bahia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2017

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

May 27, 2017

First Submitted That Met QC Criteria

May 27, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 31, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Federal University of Bahia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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