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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Berg Balance Scale (BBS); Tinetti Gait Scale (TGS) 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).

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

Conditions
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Stroke, Cerebrovascular Disorders

Intervention / Treatment
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* Other: Virtual Rehabilitation
* Other: Conventional therapeutic exercises
* Other: Virtual Rehabilitation and Conventional Therapeutic Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual Rehabilitation - VR<br>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). | Other: Virtual Rehabilitation<br>* It is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients.<br>* Other names: Wii-rehabilitation;|
| Active Comparator: Conventional Therapeutic Exercises - CTE<br>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; | Other: Conventional therapeutic exercises<br>* It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.<br>* Other names: PNF method;|
| Experimental: VR and CTE<br>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. | Other: Virtual Rehabilitation and Conventional Therapeutic Exercise<br>* It is the use of the conventional exercises and of the NW for rehabilitation of balance and gait in post-stroke patients.<br>* Other names: Diagonals of PNF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Hemiparesis, Physical Therapy, Virtual Reality Exposure Therapy, Video Games