Virtual Rehabilitation and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke
The Effect of Virtual Rehabilitation With Nintendo Wii ® and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jun 2015
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 12, 2017
December 1, 2017
1 year
March 17, 2016
December 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
TGS
8 weeks
QLSSS
8 weeks
Study Arms (3)
Virtual Rehabilitation - VR
ACTIVE COMPARATORA 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).
Conventional Therapeutic Exercises - CTE
ACTIVE COMPARATORA program of conventional therapeutic exercises (G1) 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 of upper limb PNF diagonal exercise (flexion-abduction-external rotation and extension-abduction-internal rotation), and 10 minutes of scapula PNF diagonal exercise (anterior and posterior elevation); b) protocol 2: 20 minutes of lower limb PNF diagonal exercise (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes of pelvis PNF diagonal exercise (anterior and posterior depression), and 10 minutes gait cycle training;
VR and CTE
EXPERIMENTALIn 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.
Interventions
It is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients.
It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.
It is the use of the conventional exercises and of the NW for rehabilitation of balance and gait in post-stroke patients.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Complex Hospital Professor Edgard Santos, Federal University of Bahia
Salvador, Estado de Bahia, 40.110-060, Brazil
Related Publications (6)
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.
PMID: 26258455BACKGROUNDSaposnik 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.
PMID: 20508185BACKGROUNDSaposnik 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.
PMID: 20088994BACKGROUNDDos Santos LR, Carregosa AA, Masruha MR, Dos Santos PA, Da Silveira Coelho 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.
PMID: 26303792BACKGROUNDKim 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.
PMID: 26834335BACKGROUNDSeo 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.
PMID: 26157240BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ailton S Melo, PhD
Federal University of Bahia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's Degree student
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 22, 2016
Study Start
June 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2017
Last Updated
December 12, 2017
Record last verified: 2017-12