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Completed

NCT Number: NCT02715817

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complex Hospital Professor Edgard Santos, Federal University of Bahia

Salvador, Estado de Bahia, 40.110-060, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Rehabilitation

Other

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

Conventional therapeutic exercises

Other

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

Virtual Rehabilitation and Conventional Therapeutic Exercise

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of Bahia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 22, 2016
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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