Cerebrovascular StrokeNCT04934787
ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
A study testing ENMS-BSF assisted gait training in people with Cerebrovascular Stroke and Foot Drop, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cerebrovascular Stroke, Foot Drop, Foot Inversion Deformity
- What is being tested?
- ENMS-BSF assisted gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Dec 2027
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 6 months after the onset of stroke
- Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score >21).
- Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance.
- Fugl-Meyer Assessment (FMA), total score on the lower limb <20
- Functional Ambulatory Category (FAC) ≥4
- Berg Balance Scale (BBS) ≥40
Who cannot join
- The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) >3.
- Receiving other lower limb rehabilitative interventions at the same time
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cherrie Mok contact
China1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Xiaoling Hu, Ph.D., +852 34003205, xiaoling.hu@polyu.edu.hk
Xiaoling Hu, Ph.D.
About this study
Official title: Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb. The device is wearable and light-in-weight for unilateral application during walking. It is hypothesized that with the intervention of the ENMS-BSF the gait pattern of persons after stroke can be improved with long-term rehabilitative effects.
- Conditions
- Cerebrovascular Stroke, Foot Drop, Foot Inversion Deformity
- Being tested
- ENMS-BSF assisted gait training
- Keywords
- Robot, Stroke, Lower limb
- Medical subject headings
- Stroke, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENMS-BSF assisted gait trainingDevice
- ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking.
- Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session.
- In each session, a participant will complete the device-assisted walking on flat ground with a natural speed and with the aid of a four-pronged cane.
| Study group | Role | What they receive |
|---|---|---|
| ENMS-BSF assisted gait training | Experimental | The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation. Receives: Device: ENMS-BSF assisted gait training |
| Partial ENMS-BSF assisted gait training | Active comparator | The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation. Receives: Device: ENMS-BSF assisted gait training |
| Sham ENMS-BSF assisted gait training | Sham comparator | The participants will only wear the device without assistance during a 20-session gait rehabilitation. Receives: Device: ENMS-BSF assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment
To evaluate the voluntary motor function of the lower limb after the interventions
Measured: before, one day after, and 3 months after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
- Responsible party
- Principal investigator, Xiaoling Hu, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934787
- Sponsor's protocol ID
- ITS/062/19
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the obtained ethical approval, all personal data of participants cannot be shared or released.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT04934787
- Acronym / sponsor ID
- ITS/062/19
- Conditions
- Cerebrovascular Stroke, Foot Drop, Foot Inversion Deformity
- Keywords
- Robot, Stroke, Lower limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jun 2021 (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.
In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb. The device is wearable and light-in-weight for unilateral application during walking. It is hypothesized that with the intervention of the ENMS-BSF the gait pattern of persons after stroke can be improved with long-term rehabilitative effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ENMS-BSF assisted gait training | Experimental | Device: ENMS-BSF assisted gait trainingThe participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation. |
| Partial ENMS-BSF assisted gait training | Active comparator | Device: ENMS-BSF assisted gait trainingThe participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation. |
| Sham ENMS-BSF assisted gait training | Sham comparator | Device: ENMS-BSF assisted gait trainingThe participants will only wear the device without assistance during a 20-session gait rehabilitation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 6 months after the onset of stroke
- Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score >21).
- Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance.
- Fugl-Meyer Assessment (FMA), total score on the lower limb <20
- Functional Ambulatory Category (FAC) ≥4
Key exclusion criteria (2 listed)
- The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) >3.
- Receiving other lower limb rehabilitative interventions at the same time
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 |
|---|---|---|
| ENMS-BSF assisted gait training1. ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking. 2. Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session. 3. In each session, a participant will complete the device-assisted walking on flat ground with a natural speed and with the aid of a four-pronged cane. | Device | ENMS-BSF assisted gait training, Partial ENMS-BSF assisted gait training, Sham ENMS-BSF assisted gait training |
Primary outcome
Change in Fugl-Meyer Assessment
Time frame: before, one day after, and 3 months after the training
To evaluate the voluntary motor function of the lower limb after the interventions
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 22 Jun 2026.
- Individual participant dataSharing planned: No. According to the obtained ethical approval, all personal data of participants cannot be shared or released.
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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.
Cherrie Mok contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENMS-BSF assisted gait training in people with Cerebrovascular Stroke and Foot Drop, run by The Hong Kong Polytechnic University at 1 site in China.
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 6 inclusion and 2 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 22 Jun 2026. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Xiaoling Hu, PhD (34003206, xiaoling.hu@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment (time frame: before, one day after, and 3 months after the training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.