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

NCT ID: NCT03171077

Last Updated: 2018-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-10

Study Completion Date

2018-01-30

Brief Summary

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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

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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).

Conditions

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Stroke Cerebrovascular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Virtual Rehabilitation

Intervention Type OTHER

It is the use of the NW games for rehabilitation of balance in post-stroke patients.

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;

Group Type EXPERIMENTAL

PNF Method

Intervention Type OTHER

It is the use of the therapeutic exercises based on the PNF diagonals for rehabilitation of balance in post-stroke patients.

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.

Group Type ACTIVE_COMPARATOR

Virtual Rehabilitation and PNF Method

Intervention Type OTHER

It is the use of the exercises based on the PNF diagonals and of the NW for rehabilitation of balance in post-stroke patients.

Interventions

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Virtual Rehabilitation

It is the use of the NW games for rehabilitation of balance in post-stroke patients.

Intervention Type OTHER

PNF Method

It is the use of the therapeutic exercises based on the PNF diagonals for rehabilitation of balance in post-stroke patients.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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NW Wii-rehabilitation Commercial Game Kabat method Diagonals of PNF Kabat method Wii-rehabilitation Commercial Game Diagonals of PNF

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Bahia

OTHER

Sponsor Role lead

Responsible Party

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Vítor Antônio dos Santos Júnior

Master's Degree student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ailton S Melo, PhD

Role: STUDY_DIRECTOR

Federal University of Bahia

Locations

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Complex Hospital Professor Edgard Santos, Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 20508185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20088994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21533334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19443347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24846875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23172402 (View on PubMed)

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.

Reference Type RESULT
PMID: 26258455 (View on PubMed)

Other Identifiers

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Federal University of Bahia

Identifier Type: -

Identifier Source: org_study_id

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