Comparison of Training in Virtual Environment With and Without Physiotherapeutic Intervention in Chronic Stroke Patients
- Conditions
- Stroke
- Interventions
- Other: Physiotherapeutic InterventionOther: No Physiotherapeutic Intervention
- Registration Number
- NCT03361241
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physiotherapeutic Intervention Physiotherapeutic Intervention Virtual reality training with physiotherapeutic intervention No Physiotherapeutic Intervention No Physiotherapeutic Intervention Virtual reality training without physiotherapeutic intervention
- Primary Outcome Measures
Name Time Method Balance Evaluation Systems Test (BESTest) 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 Outcome Measures
Name Time Method The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE) Up to 3 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
Rhythmic Weight Shift Up to three months The Rhythmic Weight Shift quantifies the subject's active weight shift ability by moving the COP cursor to match velocity and direction of a moving visual target in the medial- lateral (ML) and anterior-posterior (AP) directions at three different velocities.
Stroke Specific quality of life scale Up to three months Stroke Quality of Life Scale is a self-report assessment that includes 12 stroke subscales with 49 items. The Stroke Specific Quality of Life Scale attempts to capture the domains of stroke 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.
6-minute walk test Up to three months 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.
Limits of Stability Up to 3 months 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).
Trial Locations
- Locations (1)
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
🇧🇷Sao Paulo, SP, Brazil