NCT04550728 · University of Maryland, Baltimore
Hybrid Robot+FES Stroke Rehabilitation
What this study is about
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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
Ankle robot training group
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.
COMBINATION_PRODUCT
Ankle robot training and functional electrical stimulation(FES) group
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.
Primary outcome measures
Fugl-Meyer Lower Extremity
Time frame: Baseline
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
Fugl-Meyer Lower Extremity
Time frame: 6 weeks
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
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.
Dorsiflexion active range of motion
Time frame: 6 weeks
Joint ankle active range of motion measured by ankle robot.
Dorsiflexion active range of motion
Time frame: 12 weeks
Joint ankle active range of motion measured by ankle robot.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Baltimore, Maryland
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Frequently asked questions
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Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 18, 2025 · Source of record for eligibility and locations