StrokePhase 1/2NCT04550728
Hybrid Robot+FES Stroke Rehabilitation
A Phase 1/2 study testing Ankle robot training group and Ankle robot training and functional electrical stimulation(FES) group in people with Stroke, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Ankle robot training group and Ankle robot training and functional electrical stimulation(FES) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Li-Qun Zhang, PhD
About this study
Official title: Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke
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.
- Conditions
- Stroke
- Being tested
- Ankle robot training group, Ankle robot training and functional electrical stimulation(FES) group
- Keywords
- stroke, functional electrical stimulation, robot training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle robot training groupCombination product
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.
Ankle robot training and functional electrical stimulation(FES) groupCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| FES+robot | Experimental | Participants in this group will have FES during ankle robot training Receives: Combination Product: Ankle robot training and functional electrical stimulation(FES) group |
| Robot | Active comparator | Participants in this group will have ankle robot training only Receives: Combination Product: Ankle robot training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Lower Extremity
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
Measured: Baseline
Fugl-Meyer Lower Extremity
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
Measured: 6 weeks
Fugl-Meyer Lower Extremity
The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.
Measured: 12 weeks
Dorsiflexion active range of motion
Joint ankle active range of motion measured by ankle robot.
Measured: Baseline
Dorsiflexion active range of motion
Joint ankle active range of motion measured by ankle robot.
Measured: 6 weeks
Dorsiflexion active range of motion
Joint ankle active range of motion measured by ankle robot.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 week
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Aug 2021
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Qun Zhang, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550728
- Sponsor's protocol ID
- HP-00089895
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang LQ, Chung SG, Bai Z, Xu D, van Rey EM, Rogers MW, Johnson ME, Roth EJ. Intelligent stretching of ankle joints with contracture/spasticity. IEEE Trans Neural Syst Rehabil Eng. 2002 Sep;10(3):149-57. doi: 10.1109/TNSRE.2002.802857.
PubMed 12503779Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil. 2005 Dec;86(12):2330-6. doi: 10.1016/j.apmr.2005.07.305.
PubMed 16344031Ren Y, Wu YN, Yang CY, Xu T, Harvey RL, Zhang LQ. Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2017 Jun;25(6):589-596. doi: 10.1109/TNSRE.2016.2584003. Epub 2016 Jun 22.
PubMed 27337720Embrey DG, Holtz SL, Alon G, Brandsma BA, McCoy SW. Functional electrical stimulation to dorsiflexors and plantar flexors during gait to improve walking in adults with chronic hemiplegia. Arch Phys Med Rehabil. 2010 May;91(5):687-96. doi: 10.1016/j.apmr.2009.12.024.
PubMed 20434604
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke
- ClinicalTrials.gov ID
- NCT04550728
- Acronym / sponsor ID
- HP-00089895
- Conditions
- Stroke
- Keywords
- stroke, functional electrical stimulation, robot training
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES+robot | Experimental | Combination Product: Ankle robot training and functional electrical stimulation(FES) groupParticipants in this group will have FES during ankle robot training |
| Robot | Active comparator | Combination Product: Ankle robot training groupParticipants in this group will have ankle robot training only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle robot training groupPatients 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 | Robot |
| Ankle robot training and functional electrical stimulation(FES) groupPatients 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. | Combination product | FES+robot |
Primary outcome
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.
18 secondary outcomes
Timed up-to-go
Time frame: Baseline
Timed up-to-go
Time frame: 6 weeks
Timed up-to-go
Time frame: 12 weeks
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: baseline
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: 6 weeks
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: 12 weeks
Brief Balance Evaluation Systems Test(Brief-BESTest)
Time frame: baseline
Brief Balance Evaluation Systems Test(Brief-BESTest)
Time frame: 6 weeks
Brief Balance Evaluation Systems Test(Brief-BESTest)
Time frame: 12 weeks
Modified Ashworth Scale (MAS)
Time frame: baseline
Modified Ashworth Scale (MAS)
Time frame: 6 weeks
Modified Ashworth Scale (MAS)
Time frame: 12 weeks
10-meter walk test (10MWT)
Time frame: baseline
10-meter walk test (10MWT)
Time frame: 6 weeks
10-meter walk test (10MWT)
Time frame: 12 weeks
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Time frame: Baseline
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Time frame: 6 weeks
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 12503779Zhang LQ, Chung SG, Bai Z, Xu D, van Rey EM, Rogers MW, Johnson ME, Roth EJ. Intelligent stretching of ankle joints with contracture/spasticity. IEEE Trans Neural Syst Rehabil Eng. 2002 Sep;10(3):149-57. doi: 10.1109/TNSRE.2002.802857.
- Background: PubMed 16344031Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil. 2005 Dec;86(12):2330-6. doi: 10.1016/j.apmr.2005.07.305.
- Background: PubMed 27337720Ren Y, Wu YN, Yang CY, Xu T, Harvey RL, Zhang LQ. Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2017 Jun;25(6):589-596. doi: 10.1109/TNSRE.2016.2584003. Epub 2016 Jun 22.
- Background: PubMed 20434604Embrey DG, Holtz SL, Alon G, Brandsma BA, McCoy SW. Functional electrical stimulation to dorsiflexors and plantar flexors during gait to improve walking in adults with chronic hemiplegia. Arch Phys Med Rehabil. 2010 May;91(5):687-96. doi: 10.1016/j.apmr.2009.12.024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ankle robot training group and Ankle robot training and functional electrical stimulation(FES) group in people with Stroke, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-qun Zhang, PhD (410 706 2145, L-Zhang@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Lower Extremity (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04550728, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.