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

Primary Purpose

Stroke, Cerebrovascular Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Virtual Rehabilitation
PNF Method
Virtual Rehabilitation and PNF Method
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Complex Hospital Professor Edgard Santos, Federal University of Bahia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Virtual Rehabilitation

PNF Method

Virtual Rehabilitation and PNF Method

Arm Description

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).

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;

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.

Outcomes

Primary Outcome Measures

Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke
Fugl-Meyer Assessment

Secondary Outcome Measures

Full Information

First Posted
May 27, 2017
Last Updated
March 31, 2018
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT03171077
Brief Title
Virtual Rehabilitation and PNF in the Recovery of the Motor Function Post Stroke
Official Title
Effectiveness of Virtual Rehabilitation and Proprioceptive Neuromuscular Facilitation in the Recovery of the Motor Function Post Stroke: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 10, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Rehabilitation
Arm Type
Active Comparator
Arm Description
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).
Arm Title
PNF Method
Arm Type
Experimental
Arm Description
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;
Arm Title
Virtual Rehabilitation and PNF Method
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Rehabilitation
Other Intervention Name(s)
NW Wii-rehabilitation Commercial Game
Intervention Description
It is the use of the NW games for rehabilitation of balance in post-stroke patients.
Intervention Type
Other
Intervention Name(s)
PNF Method
Other Intervention Name(s)
Kabat method Diagonals of PNF
Intervention Description
It is the use of the therapeutic exercises based on the PNF diagonals for rehabilitation of balance in post-stroke patients.
Intervention Type
Other
Intervention Name(s)
Virtual Rehabilitation and PNF Method
Other Intervention Name(s)
Kabat method Wii-rehabilitation Commercial Game Diagonals of PNF
Intervention Description
It is the use of the exercises based on the PNF diagonals and of the NW for rehabilitation of balance in post-stroke patients.
Primary Outcome Measure Information:
Title
Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke
Description
Fugl-Meyer Assessment
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ailton S Melo, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
Facility Information:
Facility Name
Complex Hospital Professor Edgard Santos, Federal University of Bahia
City
Salvador
State/Province
BA
ZIP/Postal Code
40.110-060
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20508185
Citation
Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
Results Reference
background
PubMed Identifier
20088994
Citation
Saposnik G, Mamdani M, Bayley M, Thorpe KE, Hall J, Cohen LG, Teasell R; EVREST Steering Committee; EVREST Study Group for the Stroke Outcome Research Canada Working Group. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system. Int J Stroke. 2010 Feb;5(1):47-51. doi: 10.1111/j.1747-4949.2009.00404.x.
Results Reference
background
PubMed Identifier
21533334
Citation
Mouawad MR, Doust CG, Max MD, McNulty PA. Wii-based movement therapy to promote improved upper extremity function post-stroke: a pilot study. J Rehabil Med. 2011 May;43(6):527-33. doi: 10.2340/16501977-0816.
Results Reference
background
PubMed Identifier
19443347
Citation
Teasell R, Meyer MJ, McClure A, Pan C, Murie-Fernandez M, Foley N, Salter K. Stroke rehabilitation: an international perspective. Top Stroke Rehabil. 2009 Jan-Feb;16(1):44-56. doi: 10.1310/tsr1601-44.
Results Reference
background
PubMed Identifier
24846875
Citation
Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
Results Reference
background
PubMed Identifier
23172402
Citation
Ribeiro T, Britto H, Oliveira D, Silva E, Galvao E, Lindquist A. Effects of treadmill training with partial body weight support and the proprioceptive neuromuscular facilitation method on hemiparetic gait: a randomized controlled study. Eur J Phys Rehabil Med. 2013 Aug;49(4):451-61. Epub 2012 Nov 20.
Results Reference
background
PubMed Identifier
26258455
Citation
da Silva Ribeiro NM, Ferraz DD, Pedreira E, Pinheiro I, da Silva Pinto AC, Neto MG, Dos Santos LR, Pozzato MG, Pinho RS, Masruha MR. Virtual rehabilitation via Nintendo Wii(R) and conventional physical therapy effectively treat post-stroke hemiparetic patients. Top Stroke Rehabil. 2015 Aug;22(4):299-305. doi: 10.1179/1074935714Z.0000000017. Epub 2015 Feb 25.
Results Reference
result

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

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