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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Balance Evaluation Systems Test (BESTest)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Single blinded (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;
- •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
Arms & Interventions
No Physiotherapeutic Intervention
Virtual reality training without physiotherapeutic intervention
Intervention: No Physiotherapeutic Intervention (Other)
Physiotherapeutic Intervention
Virtual reality training with physiotherapeutic intervention
Intervention: Physiotherapeutic Intervention (Other)
Outcomes
Primary Outcomes
Balance Evaluation Systems Test (BESTest)
Time Frame: Up to 3 months
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.
Secondary Outcomes
- The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)(Up to 3 months)
- Rhythmic Weight Shift(Up to three months)
- Stroke Specific quality of life scale(Up to three months)
- 6-minute walk test(Up to three months)
- Limits of Stability(Up to 3 months)