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

Sponsor
Federal University of Bahia (Other)
Overall Status
Completed
CT.gov ID
NCT03171077
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
7.7
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Rehabilitation
  • Other: PNF Method
  • Other: Virtual Rehabilitation and PNF Method
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Virtual Rehabilitation and Proprioceptive Neuromuscular Facilitation in the Recovery of the Motor Function Post Stroke: A Randomized Clinical Trial
Actual Study Start Date :
Jun 10, 2017
Actual Primary Completion Date :
Oct 30, 2017
Actual Study Completion Date :
Jan 30, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke [8 weeks]

      Fugl-Meyer Assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Complex Hospital Professor Edgard Santos, Federal University of Bahia Salvador BA Brazil 40.110-060

    Sponsors and Collaborators

    • Federal University of Bahia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Vítor Antônio dos Santos Júnior, Master's Degree student, Federal University of Bahia
    ClinicalTrials.gov Identifier:
    NCT03171077
    Other Study ID Numbers:
    • Federal University of Bahia
    First Posted:
    May 31, 2017
    Last Update Posted:
    Apr 3, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Stroke
    Cerebrovascular Disorders

    Study Results

    No Results Posted as of Apr 3, 2018