Effects of Training in a Virtual Environment in Chronic Stroke Patients

Study Overview
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Brief Summary
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The objective of this work will be compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group, 20 each one.

Detailed Description
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The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, motor function, balance and quality of life in chronic stroke patients. It is a prospective, single-blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty chronic stroke patients are 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 performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 8 Wii Fit games which stimulate motor and cognitive functions. The main outcome measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2); Balance Evaluation Systems Test (BESTest);(3) the Stroke-Specific Quality of Life (SS-QOL); (4) 6- minute walk test (6MWT) and (5) The limits of stability (LOS).

Official Title
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Effects of Training in a Virtual Environment on the Motor Function,Postural Control and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Other: Virtual Reality Training
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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; the absence of a musculoskeletal condition that could potentially affect the ability to walk safely; the absence of serious visual impairment or a hearing disorder; power of at least grade 3 in the hemiplegic lower extremity; able to understand and follow simple instructions. Exclusion Criteria: a Montreal Cognitive Assessment (MoCA) score of < 20; severe dementia or aphasia; hemispatial neglect, ataxia or any other cerebellar symptom; inability to stand without minimal assist; Impaired vision Uncontrollable medical complications participation in other studies or rehabilitation programs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Training<br>The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit. | Other: Virtual Reality Training<br>* The participants of the study will be trained 8 balance games during 14 sessions<br>|
| Active Comparator: Control group: Physical Therapy<br>The Control Group will be trained by conventional Physical Therapy exercises. | Other: Physical Therapy<br>* Patients of the control group will be trained with balance exercises.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE) | FMA-LE is a subscale measuring lower limb motor recovery. It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 2 months | 
| 6-minute walk test | The 6MWT is a practical simple test. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). The 6MWT has been used as a measure of functional status of patients. | Up to 2 months | 
| Stroke speciﬁc quality of life scale | Stroke Speciﬁc Quality of Life Scale is a self-report assessment that includes 12 stroke speciﬁc subscales with 49 items. The Stroke Speciﬁc Quality of Life Scale attempts to capture the domains of stroke speciﬁc QOL that are insufficiently assessed with generic QOL measures. The 12 subscales, which are unidimensional, are Energy, Family Role, Language, Mobility, Mood, Personality, Self-Care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work-Productivity. Participants responded to each item on a 5-point scale. Domain scores are the averages of the item scores, and the total score is the average of the domain scores. All summary scores therefore range from 1 to 5. Higher scores indicate better function. | Up to 2 months | 
| Limits of Stability | The Limits of Stability subtest quantifies the maximum distance a person can intentionally displace their center of pressure (COP) from start position of midline COP centered over the base of support to eight targets. Location and movement of the COP was indicated by a cursor display projected on a screen in front of the subject. As targets were highlighted, the subject was to move the COP cursor quickly and accurately as possible towards a target located on the Limits of Stability perimeter and hold position as close to the target as possible. The parameters include COP movement velocity and directional control (% to target). | Up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postural Balance, Virtual Reality Exposure Therapy, Gait, Stroke