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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
Sponsor:
Information provided by (Responsible Party):
Luan Rafael Aguiar dos Santos, Federal University of Bahia

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.

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

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • NW
  • Non-immersive virtual reality
  • Commercial Game
  • Wii-rehabilitation

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.
Other Names:
  • Conventional physical therapy
  • Conventional exercises to improve balance and gait
  • Diagonals of PNF
  • PNF method

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.
Other Names:
  • Non-immersive virtual reality
  • Wii-rehabilitation
  • Commercial Game
  • Conventional exercises to improve balance and gait
  • Diagonals of PNF




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Brazil
Complex Hospital Professor Edgard Santos, Federal University of Bahia
Salvador, Bahia, Brazil, 40.110-060
Sponsors and Collaborators
Federal University of Bahia
Investigators
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Study Director: Ailton S Melo, PhD Federal University of Bahia
Additional Information:
Publications:

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Responsible Party: Luan Rafael Aguiar dos Santos, Master's Degree student, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT02715817    
Other Study ID Numbers: 943.738
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Luan Rafael Aguiar dos Santos, Federal University of Bahia:
Stroke
Hemiparesis
Physical Therapy
Virtual Reality Exposure Therapy
Video Games
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases