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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171077
• Other study ID #: Federal University of Bahia
• Status: Completed
• Phase: N/A
• First received: May 27, 2017
• Last updated: March 31, 2018
• Start date: June 10, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: March 2018
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Stroke

Intervention

Other:
• Virtual Rehabilitation
It is the use of the NW games for rehabilitation of balance in post-stroke patients.
• PNF Method
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
It is the use of the exercises based on the PNF diagonals and of the NW for rehabilitation of balance in post-stroke patients.

Locations

Country	Name	City	State
Brazil	Complex Hospital Professor Edgard Santos, Federal University of Bahia	Salvador	BA

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

da Silva Ribeiro NM, Ferraz DD, Pedreira É, Pinheiro Í, da Silva Pinto AC, Neto MG, Dos Santos LR, Pozzato MG, Pinho RS, Masruha MR. Virtual rehabilitation via Nintendo Wii® and conventional physical therapy effectively treat post-stroke hemiparetic patie — View 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. — View Citation

Ribeiro T, Britto H, Oliveira D, Silva E, Galvão 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke	Fugl-Meyer Assessment	8 weeks