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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Virtual Reality Training
The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.
Intervention: Virtual Reality Training (Other)
Control group: Physical Therapy
The Control Group will be trained by conventional Physical Therapy exercises.
Intervention: Physical Therapy (Other)
Outcomes
Primary Outcomes
The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
Time Frame: up to 2 months
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
Secondary Outcomes
- Balance Evaluation Systems Test (BESTest)(Up 2 months)
- 6-minute walk test(Up to 2 months)
- Stroke specific quality of life scale(Up to 2 months)
- Limits of Stability(Up to 2 months)