Virtual Rehabilitation and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke
NCT ID: NCT02715817
Last Updated: 2017-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2015-06-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Virtual Rehabilitation - VR
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).
Virtual Rehabilitation
It is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients.
Conventional Therapeutic Exercises - CTE
A 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;
Conventional therapeutic exercises
It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.
VR and CTE
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of Bahia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luan Rafael Aguiar dos Santos
Master's Degree student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ailton S Melo, PhD
Role: STUDY_DIRECTOR
Federal University of Bahia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Complex Hospital Professor Edgard Santos, Federal University of Bahia
Salvador, Estado de Bahia, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Dos 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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
World Health Organization. Health topics: Stroke, Cerebrovascular accident.
Evidence-Based Review of Stroke Rehabilitation (EBRSR)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
943.738
Identifier Type: -
Identifier Source: org_study_id