University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Location status: Recruiting
Location contact
Li-Qun Zhang, PhD
CONTACT
Recruiting
NCT Number: NCT04550728
Hybrid Robot+FES Stroke Rehabilitation
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age 18-85;
- Able to ambulate at least 10 meters without human assistance, with or without an assistive device
- ≥ 6 months post stroke;
- having a caregiver to assist in training at home.
Exclusion criteria
- having expressive and receptive aphasia;
- an inability to follow multi-step commands;
- enrolled in another lower limb rehabilitation program;
- having severe pain in the paralyzed lower-limb;
- >30º ankle plantar flexion contracture;
- Having implanted electronic device such as a pacemaker, spinal cord, or deep brain stimulator because FES may potentially interfere with their functions.
Treatment and study plan
Ankle robot training group
Combination ProductPatients 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.
Ankle robot training and functional electrical stimulation(FES) group
Combination ProductPatients 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.
Primary outcomes
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Fugl-Meyer Lower Extremity
Time frame: Baseline
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
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Fugl-Meyer Lower Extremity
Time frame: 6 weeks
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
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Fugl-Meyer Lower Extremity
Time frame: 12 weeks
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
-
Dorsiflexion active range of motion
Time frame: Baseline
Joint ankle active range of motion measured by ankle robot.
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Dorsiflexion active range of motion
Time frame: 6 weeks
Joint ankle active range of motion measured by ankle robot.
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Dorsiflexion active range of motion
Time frame: 12 weeks
Joint ankle active range of motion measured by ankle robot.
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6 minutes walking test
Time frame: Baseline
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.
-
6 minutes walking test
Time frame: 6 weeks
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.
-
6 minutes walking test
Time frame: 12 weeks
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.
-
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
Time frame: Baseline
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.
-
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
Time frame: 6 week
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.
-
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
Time frame: 12 week
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.
-
Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
Time frame: Baseline
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.
-
Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
Time frame: 6 week
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.
-
Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
Time frame: 12 week
B-model ultrasound will be used to assess the muscle thickness, muscle fiber pennation angle. Elasticity will be measured using ultrasound elastography.
Secondary outcomes
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Timed up-to-go
Time frame: Baseline
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.
-
Timed up-to-go
Time frame: 6 weeks
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.
-
Timed up-to-go
Time frame: 12 weeks
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.
-
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: baseline
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).
-
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: 6 weeks
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).
-
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: 12 weeks
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).
-
Brief Balance Evaluation Systems Test(Brief-BESTest)
Time frame: baseline
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.
-
Brief Balance Evaluation Systems Test(Brief-BESTest)
Time frame: 6 weeks
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.
-
Brief Balance Evaluation Systems Test(Brief-BESTest)
Time frame: 12 weeks
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.
-
Modified Ashworth Scale (MAS)
Time frame: baseline
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.
-
Modified Ashworth Scale (MAS)
Time frame: 6 weeks
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.
-
Modified Ashworth Scale (MAS)
Time frame: 12 weeks
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.
-
10-meter walk test (10MWT)
Time frame: baseline
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.
-
10-meter walk test (10MWT)
Time frame: 6 weeks
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.
-
10-meter walk test (10MWT)
Time frame: 12 weeks
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.
-
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Time frame: Baseline
Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.
-
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Time frame: 6 weeks
Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.
-
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Time frame: 12 weeks
Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Maryland, Baltimore
Other
Registry information
Official study title
Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke
Important dates
- Study start
- 2021
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 16, 2020
- Registry last updated
- Dec 18, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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