Virtual Rehabilitation and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke
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|ClinicalTrials.gov Identifier: NCT02715817|
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke Cerebrovascular Disorders||Other: Virtual Rehabilitation Other: Conventional therapeutic exercises Other: Virtual Rehabilitation and Conventional Therapeutic Exercise||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Virtual Rehabilitation With Nintendo Wii ® and Conventional Therapeutic Exercises in the Treatment of Individuals Post Stroke|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2017|
Active Comparator: 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).
Other: Virtual Rehabilitation
It is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients.
Active Comparator: 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;
Other: Conventional therapeutic exercises
It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.
Experimental: 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.
Other: 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.
- BBS [ Time Frame: 8 weeks ]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.
- TGS [ Time Frame: 8 weeks ]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.
- QLSSS [ Time Frame: 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715817
|Complex Hospital Professor Edgard Santos, Federal University of Bahia|
|Salvador, Bahia, Brazil, 40.110-060|
|Study Director:||Ailton S Melo, PhD||Federal University of Bahia|