Upper Limb RehabilitationNCT03752775
Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke
A study testing Robot assisted upper limb rehabilitation in people with Upper Limb Rehabilitation, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Upper Limb Rehabilitation
- What is being tested?
- Robot assisted upper limb rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 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
- For the subacute groups:
- Two weeks after the onset of stroke, however less than 0.5 year
- Mini-Mental State Examination (MMSE)>21
- Able to sit up for at least 1 hour
- Fugl-Meyer Assessment (FMA) upper limb <30
- Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
Show all 14Show fewer
- Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)
- For the chronic device assisted group:
- At least 0.5 year after the onset of stroke
- Mini-Mental State Examination (MMSE)>21
- Able to sit up for at least 1 hour
- Fugl-Meyer Assessment (FMA) upper limb <30
- Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
- Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)
Who cannot join
- Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions:
- Currently pregnant
- Dysphasia (language deficiency)
- Post-stroke neglect
- Pacemaker implantation,
- Involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb
- The overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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: Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke
A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.
Read the detailed description
A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to wear, and can support the motions at the elbow, the wrist and the fingers. The device is a mobile system interfaced with a mobile app by a user.
The device assisted upper limb rehabilitation will be applied to inpatients with subacute stroke. The rehabilitation effects on the motor restoration in the upper limb will be compared with the conventional physical and occupational therapies. The rehabilitation effects of the device assisted training also will be evaluated on patients with chronic stroke. The motor improvements after training will be investigated by comparing the pre- and post- clinical assessments. It is hypothesized that the device assisted upper limb rehabilitation will be effective in both subacute and chronic patients.
- Conditions
- Upper Limb Rehabilitation
- Being tested
- Robot assisted upper limb rehabilitation
- Keywords
- stroke, upper limb, Joint coordination
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted upper limb rehabilitationDevice
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| subacute device assisted group | Experimental | Not described Receives: Device: Robot assisted upper limb rehabilitation |
| subacute conventional group | Active comparator | Not described Receives: Device: Robot assisted upper limb rehabilitation |
| chronic device assisted group | Other | Not described Receives: Device: Robot assisted upper limb rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA) of the Upper Limb before the training
Measured: For each subject, the FMA score will be measured one day before the training.
Fugl-Meyer Assessment (FMA) of the Upper Limb after the training
Measured: For each subject, the FMA score will be measured one day after the 20-session training program.
Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up
Measured: For each subject, the FMA score will be measured 3 months later after the last day of the training.
Secondary outcomes (2)
Modified Ashworth Scale (MAS)
Measured: For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
Action Research Arm Test (ARAT)
Measured: For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Nov 2018
- 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Limb RehabilitationStudies of the same condition, open and under way.
- 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
- Model description
- The device assisted treatment will be administrated to patients with subacute stroke and chronic stroke. The subacute stroke group will be compared in parallel with a control group receive the conventional physical and occupational therapies.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Hu, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752775
- Sponsor's protocol ID
- ITS/073/16
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2018
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nam C, Zhang B, Chow T, Ye F, Huang Y, Guo Z, Li W, Rong W, Hu X, Poon W. Home-based self-help telerehabilitation of the upper limb assisted by an electromyography-driven wrist/hand exoneuromusculoskeleton after stroke. J Neuroeng Rehabil. 2021 Sep 15;18(1):137. doi: 10.1186/s12984-021-00930-3.
PubMed 34526058Nam C, Rong W, Li W, Cheung C, Ngai W, Cheung T, Pang M, Li L, Hu J, Wai H, Hu X. An Exoneuromusculoskeleton for Self-Help Upper Limb Rehabilitation After Stroke. Soft Robot. 2022 Feb;9(1):14-35. doi: 10.1089/soro.2020.0090. Epub 2020 Dec 3.
PubMed 33271057
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT03752775
- Acronym / sponsor ID
- ITS/073/16
- Conditions
- Upper Limb Rehabilitation
- Keywords
- stroke, upper limb, Joint coordination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Nov 2018 (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.
A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.
Detailed description
A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to wear, and can support the motions at the elbow, the wrist and the fingers. The device is a mobile system interfaced with a mobile app by a user.
The device assisted upper limb rehabilitation will be applied to inpatients with subacute stroke. The rehabilitation effects on the motor restoration in the upper limb will be compared with the conventional physical and occupational therapies. The rehabilitation effects of the device assisted training also will be evaluated on patients with chronic stroke. The motor improvements after training will be investigated by comparing the pre- and post- clinical assessments. It is hypothesized that the device assisted upper limb rehabilitation will be effective in both subacute and chronic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The device assisted treatment will be administrated to patients with subacute stroke and chronic stroke. The subacute stroke group will be compared in parallel with a control group receive the conventional physical and occupational therapies.
| Arm | Type | Receives |
|---|---|---|
| subacute device assisted group | Experimental | Device: Robot assisted upper limb rehabilitation |
| subacute conventional group | Active comparator | Device: Robot assisted upper limb rehabilitation |
| chronic device assisted group | Other | Device: Robot assisted upper limb rehabilitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Two weeks after the onset of stroke, however less than 0.5 year
- Mini-Mental State Examination (MMSE)>21
- Able to sit up for at least 1 hour
- Fugl-Meyer Assessment (FMA) upper limb <30
- Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
Key exclusion criteria (7 listed)
- Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions:
- Currently pregnant
- Dysphasia (language deficiency)
- Post-stroke neglect
- Pacemaker implantation,
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 |
|---|---|---|
| Robot assisted upper limb rehabilitationThe patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour. | Device | chronic device assisted group, subacute conventional group, subacute device assisted group |
Primary outcome
Fugl-Meyer Assessment (FMA) of the Upper Limb before the training
Time frame: For each subject, the FMA score will be measured one day before the training.
Fugl-Meyer Assessment (FMA) of the Upper Limb after the training
Time frame: For each subject, the FMA score will be measured one day after the 20-session training program.
Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up
Time frame: For each subject, the FMA score will be measured 3 months later after the last day of the training.
2 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
Action Research Arm Test (ARAT)
Time frame: For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
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 23 Jun 2026.
- Derived from this study: PubMed 34526058Nam C, Zhang B, Chow T, Ye F, Huang Y, Guo Z, Li W, Rong W, Hu X, Poon W. Home-based self-help telerehabilitation of the upper limb assisted by an electromyography-driven wrist/hand exoneuromusculoskeleton after stroke. J Neuroeng Rehabil. 2021 Sep 15;18(1):137. doi: 10.1186/s12984-021-00930-3.
- Derived from this study: PubMed 33271057Nam C, Rong W, Li W, Cheung C, Ngai W, Cheung T, Pang M, Li L, Hu J, Wai H, Hu X. An Exoneuromusculoskeleton for Self-Help Upper Limb Rehabilitation After Stroke. Soft Robot. 2022 Feb;9(1):14-35. doi: 10.1089/soro.2020.0090. Epub 2020 Dec 3.
- 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 study testing Robot assisted upper limb rehabilitation in people with Upper Limb Rehabilitation, 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 14 inclusion and 7 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 23 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. 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?
Fugl-Meyer Assessment (FMA) of the Upper Limb before the training (time frame: For each subject, the FMA score will be measured one day before the training.). The study lists 3 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 NCT03752775, which also lists 2 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 23 Jun 2026.