Comparison of Training in Virtual Environment With and Without Physiotherapeutic Intervention in Chronic Stroke Patients

NCT03361241 | Completed

• 1 other identifier: USPCR001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of balance training in a virtual environment with and without physiotherapeutic intervention on the motor function, balance and gait in chronic stroke patients. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group.

Conditions

Stroke

Keywords

Stroke; Postural Balance; Motor Function; Gait; Virtual Reality Exposure Therapy; Physiotherapist

Outcome Measures

Primary Outcomes (1)

• Balance Evaluation Systems Test (BESTest)

  Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.

  Up to 3 months

Secondary Outcomes (5)

• The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)

  Up to 3 months

• 6-minute walk test

  Up to three months

• Limits of Stability

  Up to 3 months

• Rhythmic Weight Shift

  Up to three months

• Stroke Specific quality of life scale

  Up to three months

Study Arms (2)

No Physiotherapeutic Intervention

EXPERIMENTAL

Virtual reality training without physiotherapeutic intervention

Other: No Physiotherapeutic Intervention

Physiotherapeutic Intervention

ACTIVE COMPARATOR

Virtual reality training with physiotherapeutic intervention

Other: Physiotherapeutic Intervention

Interventions

No Physiotherapeutic Intervention OTHER

Experimental group will perform a balance training program in a virtual environment (using a gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) without verbal/manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the two attempts of the training no manual or verbal assistance will be provided. Physiotherapist participation during training will be restricted to ensuring patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game at the end of each attempt.

Also known as: Experimental Group

No Physiotherapeutic Intervention

Physiotherapeutic Intervention OTHER

Control group will perform a balance training program in a virtual environment (gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) with verbal and manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the first attempt of the training physiotherapist will provide manual and verbal assistance, providing corrections on movement (avoiding compensatory movements). In the second attempt, no manual or verbal assistance will be provided (only ensuring patient safety, providing motivational verbal stimuli), allowing the patient to organize his or her performance.

Also known as: Control Group

Physiotherapeutic Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemiparetic status resulting from a single stroke at least 6 months earlier;
• the ability to walk 10 m independently with or without an assistive device;
• a Montreal Cognitive Assessment (MoCA) score of ≥ 20;
• the absence of a musculoskeletal condition that could potentially affect the ability to stand or walk safely;
• the absence of serious visual impairment or a hearing disorder;
• muscle strength ≥ 3 in lower limbs;
• ability to understand and follow simple instructions.

You may not qualify if:

• severe dementia or aphasia;
• hemispatial neglect, ataxia or any other cerebellar symptom;
• inability to stand without minimal assist;
• uncontrollable medical complications
• participation in other studies or rehabilitation programs

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

São Paulo, São Paulo, 05360-160, Brazil

Location

Related Publications (12)

• Adamson J, Beswick A, Ebrahim S. Is stroke the most common cause of disability? J Stroke Cerebrovasc Dis. 2004 Jul-Aug;13(4):171-7. doi: 10.1016/j.jstrokecerebrovasdis.2004.06.003.

  PMID: 17903971 BACKGROUND

• Borghese NA, Pirovano M, Lanzi PL, Wuest S, de Bruin ED. Computational Intelligence and Game Design for Effective At-Home Stroke Rehabilitation. Games Health J. 2013 Apr;2(2):81-88. doi: 10.1089/g4h.2012.0073.

  PMID: 24761321 BACKGROUND

• Broeren J, Claesson L, Goude D, Rydmark M, Sunnerhagen KS. Virtual rehabilitation in an activity centre for community-dwelling persons with stroke. The possibilities of 3-dimensional computer games. Cerebrovasc Dis. 2008;26(3):289-96. doi: 10.1159/000149576. Epub 2008 Jul 31.

  PMID: 18667809 BACKGROUND

• Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20.

  PMID: 22713539 BACKGROUND

• Laufer Y, Dar G, Kodesh E. Does a Wii-based exercise program enhance balance control of independently functioning older adults? A systematic review. Clin Interv Aging. 2014 Oct 23;9:1803-13. doi: 10.2147/CIA.S69673. eCollection 2014.

  PMID: 25364238 BACKGROUND

• Mancini M, Horak FB. The relevance of clinical balance assessment tools to differentiate balance deficits. Eur J Phys Rehabil Med. 2010 Jun;46(2):239-48.

  PMID: 20485226 BACKGROUND

• Yatar GI, Yildirim SA. Wii Fit balance training or progressive balance training in patients with chronic stroke: a randomised controlled trial. J Phys Ther Sci. 2015 Apr;27(4):1145-51. doi: 10.1589/jpts.27.1145. Epub 2015 Apr 30.

  PMID: 25995576 BACKGROUND

• Dong Y, Sharma VK, Chan BP, Venketasubramanian N, Teoh HL, Seet RC, Tanicala S, Chan YH, Chen C. The Montreal Cognitive Assessment (MoCA) is superior to the Mini-Mental State Examination (MMSE) for the detection of vascular cognitive impairment after acute stroke. J Neurol Sci. 2010 Dec 15;299(1-2):15-8. doi: 10.1016/j.jns.2010.08.051.

  PMID: 20889166 BACKGROUND

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 BACKGROUND

• Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.

  PMID: 19329772 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999 Jul;30(7):1362-9. doi: 10.1161/01.str.30.7.1362.

  PMID: 10390308 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maria Elisa P Piemonte, PT, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Mariana A Lourenço, PT,Ms Student

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Tatiana P Oliveira, PT,PhD Student

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Camila S Miranda, PT, MS

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blinded (outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: April 2, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2019
• Last Updated: February 18, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)