Virtual Rehabilitation and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke

Stroke Clinical Trial

Official title:

The Effect of Virtual Rehabilitation With Nintendo Wii ® and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715817
• Other study ID #: 943.738
• Status: Completed
• Phase: N/A
• First received: March 17, 2016
• Last updated: December 10, 2017
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: December 2017
• 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 the use the Nintendo Wii® (NW) and conventional therapeutic exercises in the rehabilitation of balance and gait of the post-stroke patients and the impact on quality of life.

Description:

This Randomised clinical trial (RCT) has 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 2017.

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, gait, and quality of life through specific validated scales:

1. Berg Balance Scale (BBS);

2. Tinetti Gait Scale (TGS)

3. Quality of Life Scale Specific for stroke (QLSSS) ;

The investigators employ a program of conventional therapeutic exercises 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: 48
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• 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; clinical diagnosis of stroke confirmed by neurological assessment report or neuroimaging;

• a stroke at least 6 months prior to the study

• the ability to walk independently with or without an assistive device;

• absence of visual or auditory deficits as reported by the subject.

Exclusion Criteria:

• score <24 on the Mini Mental State Examination;

• other associated neurological conditions;

• other orthopedic injuries that could impair mobility and make the execution of the proposed activity impossible;

• participation in other physical 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 and gaite in post-stroke patients.
• Conventional therapeutic exercises
It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.
• Virtual Rehabilitation and Conventional Therapeutic Exercise
It is the use of the conventional exercises and of the NW for rehabilitation of balance and gait in post-stroke patients.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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 patients. Top Stroke Rehabil. 2015 Aug;22(4):299-305. doi: 10.1179/1074935714Z.0000000017. Epub 2015 Feb 25. — View Citation

Dos Santos LR, Carregosa AA, Masruha MR, Dos Santos PA, Da Silveira Coêlho ML, Ferraz DD, Da Silva Ribeiro NM. The Use of Nintendo Wii in the Rehabilitation of Poststroke Patients: A Systematic Review. J Stroke Cerebrovasc Dis. 2015 Oct;24(10):2298-305. doi: 10.1016/j.jstrokecerebrovasdis.2015.06.010. Epub 2015 Aug 21. Review. — View Citation

Kim K, Lee DK, Jung SI. Effect of coordination movement using the PNF pattern underwater on the balance and gait of stroke patients. J Phys Ther Sci. 2015 Dec;27(12):3699-701. doi: 10.1589/jpts.27.3699. Epub 2015 Dec 28. — 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

Seo K, Park SH, Park K. The effects of stair gait training using proprioceptive neuromuscular facilitation on stroke patients' dynamic balance ability. J Phys Ther Sci. 2015 May;27(5):1459-62. doi: 10.1589/jpts.27.1459. Epub 2015 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BBS	It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score.	8 weeks
Secondary	TGS	It is a 12-point instrument of observational analysis of gait ability. The count for each exercise ranges from 0 to 1 or from 0 to 2, with a lower score indicating a poorer physical ability.	8 weeks
Secondary	QLSSS	The QLSS was developed to measure the quality of life of patients with stroke sequela.It contains 49 items arranged into 12 fields, and the score for each item ranges from 1 to 5 points and the total score can range from 49 to 245, so that the lower the score, the greater the degree of dependence and difficult to perform tasks, which indicates a worse perception of quality of life.	8 weeks

External Links

•   Evidence-Based Review of Stroke Rehabilitation (EBRSR)
•   World Health Organization. Health topics: Stroke, Cerebrovascular accident.