Clinical trial NCT03361241: Comparison of Training in Virtual Environment With and Without Physiotherapeutic Intervention in Chronic Stroke Patients
Official title: Comparison of Effects of Training in a Virtual Environment With and Without Physiotherapeutic Intervention on the Motor Function, Postural Control and Gait in Chronic Stroke Patients : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Postural Balance
Motor Function
Gait
Virtual Reality Exposure Therapy
Physiotherapist
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Detailed description: The aim of this study is to compare the effects of a balance training program in a virtual environment (using a gaming system with balance board device) with and without verbal/manual 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 chronic stroke patients will be randomly in control and experimental group, 20 each one. Both groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups will perform more 30 minutes of balance training using eight Wii Fit games which stimulate motor and cognitive functions.

The main outcome measures will be: the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); Balance Evaluation Systems Test (BESTest) and 6- minute walk test (6MWT).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Balance Evaluation Systems Test (BESTest)
timeFrame: Up to 3 months
Secondary outcomes:
measure: The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
timeFrame: Up to 3 months
measure: 6-minute walk test
timeFrame: Up to three months
measure: Limits of Stability
timeFrame: Up to 3 months
measure: Rhythmic Weight Shift
timeFrame: Up to three months
measure: Stroke Speciﬁc quality of life scale
timeFrame: Up to three months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Maria Elisa P Piemonte, PT, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Mariana A Lourenço, PT,Ms Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Tatiana P Oliveira, PT,PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Camila S Miranda, PT, MS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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