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CompletedNCT02715817Updated Dec 12, 2017

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

An interventional study of Virtual Rehabilitation and Conventional therapeutic exercises in Stroke and Cerebrovascular Disorders, sponsored by Federal University of Bahia. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-12.

Sponsored by Federal University of Bahia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Stroke
  • Cerebrovascular Disorders

Keywords

  • Stroke
  • Hemiparesis
  • Physical Therapy
  • Virtual Reality Exposure Therapy
  • Video Games
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Federal University of Bahia is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • OtherVirtual Rehabilitation

    It is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients.

    Also known as: NW, Non-immersive virtual reality, Commercial Game, Wii-rehabilitation

  • OtherConventional therapeutic exercises

    It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.

    Also known as: Conventional physical therapy, Conventional exercises to improve balance and gait, Diagonals of PNF, PNF method

  • OtherVirtual 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.

    Also known as: Non-immersive virtual reality, Wii-rehabilitation, Commercial Game, Conventional exercises to improve balance and gait, Diagonals of PNF

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Complex Hospital Professor Edgard Santos, Federal University of Bahia
    Salvador, Bahia 40.110-060, Brazil
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References and documents

Publications

  • 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. PubMed 26258455 ↗
  • 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. PubMed 20508185 ↗
  • 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. PubMed 20088994 ↗
  • 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. PubMed 26303792 ↗
  • 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. PubMed 26834335 ↗
  • 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. PubMed 26157240 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02715817
Lead sponsor
Federal University of Bahia
Responsible party
Luan Rafael Aguiar dos Santos (Master's Degree student, Federal University of Bahia) — Principal investigator
First posted
Mar 22, 2016
Start date
Jun 2015
Primary completion
Jun 2016
Completion
Jun 2017
Last update
Dec 12, 2017

Study contacts

Ailton S Melo, PhD
study director · Federal University of Bahia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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