The investigators have developed a novel robot-guided stretching under intelligent control and combine it with active movement training, which helped increase joint ROM, reduce spasticity and joint stiffness, increase muscle force output, and improve locomotion. However, for stroke survivors with sensorimotor impairment, their peripheral muscle may not sufficiently be recruited. Functional electrical stimulation (FES), has been shown its advantage to activate the peripheral muscles for people with neurological conditions. The investigators thus make a hybrid robot-FES rehabilitation system, combining the advantage of robot and FES technologies for stroke motor recovery. The investigators further would like to translate the technologies from lab to home-based training. Thus, the investigators will conduct a randomized, controlled, primarily home-based clinical trial using an ankle robot alone or combined with functional electrical stimulation (FES) to treat sensorimotor and locomotion impairments post-stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Patients will be seated with the paretic foot strapped to the footplate the knee at full extension. The operator will set up and measure (using the robot) ankle passive DF and PF ROM limits. The robot training will include passive stretching, robot interactive game-based training, and cool-down stretching.
Patients will use the ankle robot device as the ankle training group. Also, water-based FES electrodes positioned inside a soft garment will be secured over the DF and PF muscles by wrapping the garment around the leg just below the knee joint. Stimulation intensity will be increased to maximal tolerance of each participant. Electrically induced contraction timing will be triggered by the ankle robot in synchrony with the ankle dorsi and plantar flexion movements.
University of Maryland School of Medicine
Baltimore, Maryland, United States
RECRUITINGFugl-Meyer Lower Extremity
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
Time frame: Baseline
Fugl-Meyer Lower Extremity
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
Time frame: 6 weeks
Fugl-Meyer Lower Extremity
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
Time frame: 12 weeks
Dorsiflexion active range of motion
Joint ankle active range of motion measured by ankle robot.
Time frame: Baseline
Dorsiflexion active range of motion
Joint ankle active range of motion measured by ankle robot.
Time frame: 6 weeks
Dorsiflexion active range of motion
Joint ankle active range of motion measured by ankle robot.
Time frame: 12 weeks
6 minutes walking test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Time frame: Baseline
6 minutes walking test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Time frame: 6 weeks
6 minutes walking test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Time frame: 12 weeks
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
B-model ultrasound will be used to scan the muscle thickness, and the image will be further proceeded to measure the muscle thickness with unit in centimetres.
Time frame: Baseline
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
B-model ultrasound will be used to scan the muscle thickness, and the image will be further proceeded to measure the muscle thickness with unit in centimetres.
Time frame: 6 week
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
B-model ultrasound will be used to scan the muscle thickness, and the image will be further proceeded to measure the muscle thickness with unit in centimetres.
Time frame: 12 week
Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
B-model ultrasound will be used to scan the muscle and the image will be further proceeded to measure the muscle fiber pennation angle with unit in degree.
Time frame: Baseline
Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
B-model ultrasound will be used to scan the muscle and the image will be further proceeded to measure the muscle fiber pennation angle with unit in degree.
Time frame: 6 week
Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
B-model ultrasound will be used to assess the muscle thickness, muscle fiber pennation angle. Elasticity will be measured using ultrasound elastography.
Time frame: 12 week
Timed up-to-go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Time frame: Baseline
Timed up-to-go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Time frame: 6 weeks
Timed up-to-go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Time frame: 12 weeks
Stroke Rehabilitation Assessment of Movement (STREAM)
Stroke Rehabilitation Assessment of Movement Measure (STREAM) provides therapists with a quantitative measurement of motor functioning and basic mobility deficits among patients who had a stroke through the performance of 30 voluntary motor tasks of the upper extremities (UE) and lower extremities (LE).
Time frame: baseline
Stroke Rehabilitation Assessment of Movement (STREAM)
Stroke Rehabilitation Assessment of Movement Measure (STREAM) provides therapists with a quantitative measurement of motor functioning and basic mobility deficits among patients who had a stroke through the performance of 30 voluntary motor tasks of the upper extremities (UE) and lower extremities (LE).
Time frame: 6 weeks
Stroke Rehabilitation Assessment of Movement (STREAM)
Stroke Rehabilitation Assessment of Movement Measure (STREAM) provides therapists with a quantitative measurement of motor functioning and basic mobility deficits among patients who had a stroke through the performance of 30 voluntary motor tasks of the upper extremities (UE) and lower extremities (LE).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 weeks
Brief Balance Evaluation Systems Test(Brief-BESTest)
The Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest), designed to assess 6 different aspects contributing to postural control in standing and walking.
Time frame: baseline
Brief Balance Evaluation Systems Test(Brief-BESTest)
The Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest), designed to assess 6 different aspects contributing to postural control in standing and walking.
Time frame: 6 weeks
Brief Balance Evaluation Systems Test(Brief-BESTest)
The Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest), designed to assess 6 different aspects contributing to postural control in standing and walking.
Time frame: 12 weeks
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.
Time frame: baseline
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.
Time frame: 6 weeks
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.
Time frame: 12 weeks
10-meter walk test (10MWT)
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Time frame: baseline
10-meter walk test (10MWT)
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Time frame: 6 weeks
10-meter walk test (10MWT)
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Time frame: 12 weeks
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.
Time frame: Baseline
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.
Time frame: 6 weeks
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.
Time frame: 12 weeks