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StrokeNCT03171077

Virtual Rehabilitation and PNF in the Recovery of the Motor Function Post Stroke

A study testing Virtual Rehabilitation, PNF Method and Virtual Rehabilitation and PNF Method in people with Stroke and Cerebrovascular Disorders, run by Federal University of Bahia at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the recovery of the motor function of poststroke hemiparesis patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Cerebrovascular Disorders
What is being tested?
Virtual Rehabilitation, PNF Method and Virtual Rehabilitation and PNF Method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
10 Jun 2017to 30 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age between 18 and 80 years, of both sexes; neurological clinical diagnosis of stroke;
  • owning grade 2-4 spasticity according to the Ashworth scale;
  • hemiparetic patients after 6 months of onset of stroke;
  • deficit moderate gait according to Functional Ambulation Classification (values ≥ 2).

Who cannot join

  • score <24 on the Mini Mental State Examination;
  • other associated neurological diseases, as well as orthopedic and no visual or hearing impairment;
  • participation in other rehabilitation programs.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Complex Hospital Professor Edgard Santos, Federal University of Bahia

    Salvador, Estado de Bahia, 40.110-060

Other trials in Brazil

About this study

Official title: Effectiveness of Virtual Rehabilitation and Proprioceptive Neuromuscular Facilitation in the Recovery of the Motor Function Post Stroke: A Randomized Clinical Trial

The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the recovery of the motor function of poststroke hemiparesis patients.

Read the detailed description

Randomised clinical trial (RCT) will be held in following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials). This RCT have 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 2016.

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 and quality of life through specific validated scales:

  1. Fugl Meyer scale (FMS);

The investigators employ an experimental program of therapeutic exercises for the PNF method 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).

Being tested
Virtual Rehabilitation, PNF Method, Virtual Rehabilitation and PNF Method
Medical subject headings
Stroke, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RehabilitationOther

    Also called NW Wii-rehabilitation Commercial Game

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

  • PNF MethodOther

    Also called Kabat method Diagonals of PNF

    It is the use of the therapeutic exercises based on the PNF diagonals for rehabilitation of balance in post-stroke patients.

  • Virtual Rehabilitation and PNF MethodOther

    Also called Kabat method Wii-rehabilitation Commercial Game Diagonals of PNF

    It is the use of the exercises based on the PNF diagonals and of the NW for rehabilitation of balance in post-stroke patients.

Study groups in NCT03171077
Study groupRoleWhat they receive
Virtual RehabilitationActive comparatorA 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).
Receives: Other: Virtual Rehabilitation
PNF MethodExperimentalA program of therapeutic exercises (G1) based on the PNF method 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 diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation), and 10 minutes diagonal exercise scapula (anterior and posterior elevation); b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;
Receives: Other: PNF Method
Virtual Rehabilitation and PNF MethodActive comparatorIn 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.
Receives: Other: Virtual Rehabilitation and PNF Method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke

    Fugl-Meyer Assessment

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2017
  2. Study start10 Jun 2017
  3. Primary completion30 Oct 2017
  4. Study completion30 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03171077
Sponsor's protocol ID
Federal University of Bahia
Status last verified
Mar 2018
First submitted
27 May 2017
Last updated
3 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Mouawad MR, Doust CG, Max MD, McNulty PA. Wii-based movement therapy to promote improved upper extremity function post-stroke: a pilot study. J Rehabil Med. 2011 May;43(6):527-33. doi: 10.2340/16501977-0816.

    PubMed 21533334

  • Teasell R, Meyer MJ, McClure A, Pan C, Murie-Fernandez M, Foley N, Salter K. Stroke rehabilitation: an international perspective. Top Stroke Rehabil. 2009 Jan-Feb;16(1):44-56. doi: 10.1310/tsr1601-44.

    PubMed 19443347

  • Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.

    PubMed 24846875

  • Ribeiro T, Britto H, Oliveira D, Silva E, Galvao E, Lindquist A. Effects of treadmill training with partial body weight support and the proprioceptive neuromuscular facilitation method on hemiparetic gait: a randomized controlled study. Eur J Phys Rehabil Med. 2013 Aug;49(4):451-61. Epub 2012 Nov 20.

    PubMed 23172402

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Rehabilitation, PNF Method and Virtual Rehabilitation and PNF Method in people with Stroke and Cerebrovascular Disorders, run by Federal University of Bahia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03171077, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.

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