StrokeNCT02117089
Upper Limb Rehabilitation After Stroke Assisted With a Hybrid Electrical Stimulation (ES)-Robot System
A study testing Electrical Stimulation; Rehabilitation Robot in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The purpose of this study is to investigate the combined training effectiveness of mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Electrical Stimulation; Rehabilitation Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to 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
- The recruited subjects will
- have unilateral ischemic brain injury or intracerebral hemorrhage at least 6 months after the onset of single stroke
- have moderate level of motor impairment in the affected upper limb, assessed by Fugl-Meyer Assessment (9<shoulder/elbow<27; 6<wrist/hand<18)
- have enough cognition to be able to follow the training protocol as assessed by Mini-metal State Examination (MMSE>21)
- have detectable EMG signals (3 times of the standard deviation above the baseline) from the upper limb muscles.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomechatronic System Using Voluntary Motor Effort (VME)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation
The purpose of this study is to investigate the combined training effectiveness of mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.
- Conditions
- Stroke
- Being tested
- Electrical Stimulation; Rehabilitation Robot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Stimulation; Rehabilitation RobotDevice
The recruited subjects will receive 20-session device assisted upper limb training with an intensity of 3 to 5 sessions/week, which will be finished within 7 consecutive weeks. In each session, the subjects will conduct the system assisted and task-oriented upper limb training for 1.5 hours.
| Study group | Role | What they receive |
|---|---|---|
| Device-assisted rehabilitation | Experimental | Not described Receives: Device: Electrical Stimulation; Rehabilitation Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment Scale after training
The Fugl-Meyer Assessment Scale for upper limb measures the voluntary motor function on the shoulder, the elbow, the wrist and hand. The full score ranges from 0 to 66. It can be further separated into two subscores, i.e., shoulder/elbow (0-42) and wrist/hand (0-24). The higher the score, the better is the related motor function.
Measured: 1) up to 7 weeks, 2) 3 months after participants finish the training
Change in Modified Ashworth Scale after training
The Modified Ashworth Scale measures the resistance of a joint during passive motion, which indicates the muscle spasticity related to the joint motion, particularly the flexors. The Modified Ashworth Scale has six levels, i.e., 0, 1, 1+, 2, 3, 4. The higher value is related to a higher joint resistance, i.e., higher muscle spasticity.
Measured: 1) up to 7 weeks, 2) 3 months after participants finish the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 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
- Investigators
- Xiaoling Hu, Ph.D., Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117089
- Sponsor's protocol ID
- ITS/033/12
- Other IDs
- ITS/033/12
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2014
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tan F, Qing W, Ip WC, Guo Z, Li Z, Zhang S, Hu X. Guided corticomuscular neuroplasticity for restoration of wrist-hand function post-stroke. J Neuroeng Rehabil. 2026 Feb 23;23(1):105. doi: 10.1186/s12984-026-01915-w.
PubMed 41731569Guo Z, Zhou S, Ji K, Zhuang Y, Song J, Nam C, Hu X, Zheng Y. Corticomuscular integrated representation of voluntary motor effort in robotic control for wrist-hand rehabilitation after stroke. J Neural Eng. 2022 Mar 9;19(2). doi: 10.1088/1741-2552/ac5757.
PubMed 35193124Ye F, Yang B, Nam C, Xie Y, Chen F, Hu X. A Data-Driven Investigation on Surface Electromyography Based Clinical Assessment in Chronic Stroke. Front Neurorobot. 2021 Jul 15;15:648855. doi: 10.3389/fnbot.2021.648855. eCollection 2021.
PubMed 34335219Qian Q, Nam C, Guo Z, Huang Y, Hu X, Ng SC, Zheng Y, Poon W. Distal versus proximal - an investigation on different supportive strategies by robots for upper limb rehabilitation after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2019 Jun 3;16(1):64. doi: 10.1186/s12984-019-0537-5.
PubMed 31159822Nam C, Rong W, Li W, Xie Y, Hu X, Zheng Y. The Effects of Upper-Limb Training Assisted with an Electromyography-Driven Neuromuscular Electrical Stimulation Robotic Hand on Chronic Stroke. Front Neurol. 2017 Dec 14;8:679. doi: 10.3389/fneur.2017.00679. eCollection 2017.
PubMed 29312116Qian Q, Hu X, Lai Q, Ng SC, Zheng Y, Poon W. Early Stroke Rehabilitation of the Upper Limb Assisted with an Electromyography-Driven Neuromuscular Electrical Stimulation-Robotic Arm. Front Neurol. 2017 Sep 4;8:447. doi: 10.3389/fneur.2017.00447. eCollection 2017.
PubMed 28928706Rong W, Li W, Pang M, Hu J, Wei X, Yang B, Wai H, Zheng X, Hu X. A Neuromuscular Electrical Stimulation (NMES) and robot hybrid system for multi-joint coordinated upper limb rehabilitation after stroke. J Neuroeng Rehabil. 2017 Apr 26;14(1):34. doi: 10.1186/s12984-017-0245-y.
PubMed 28446181
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechatronic System Using Voluntary Motor Effort (VME)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation
- ClinicalTrials.gov ID
- NCT02117089
- Acronym / sponsor ID
- ITS/033/12
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Apr 2014 (estimated)
- 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 purpose of this study is to investigate the combined training effectiveness of mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device-assisted rehabilitation | Experimental | Device: Electrical Stimulation; Rehabilitation Robot |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The recruited subjects will
- have unilateral ischemic brain injury or intracerebral hemorrhage at least 6 months after the onset of single stroke
- have moderate level of motor impairment in the affected upper limb, assessed by Fugl-Meyer Assessment (9<shoulder/elbow<27; 6<wrist/hand<18)
- have enough cognition to be able to follow the training protocol as assessed by Mini-metal State Examination (MMSE>21)
- have detectable EMG signals (3 times of the standard deviation above the baseline) from the upper limb muscles.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Electrical Stimulation; Rehabilitation RobotThe recruited subjects will receive 20-session device assisted upper limb training with an intensity of 3 to 5 sessions/week, which will be finished within 7 consecutive weeks. In each session, the subjects will conduct the system assisted and task-oriented upper limb training for 1.5 hours. | Device | Device-assisted rehabilitation |
Primary outcome
Change in Fugl-Meyer Assessment Scale after training
Time frame: 1) up to 7 weeks, 2) 3 months after participants finish the training
The Fugl-Meyer Assessment Scale for upper limb measures the voluntary motor function on the shoulder, the elbow, the wrist and hand. The full score ranges from 0 to 66. It can be further separated into two subscores, i.e., shoulder/elbow (0-42) and wrist/hand (0-24). The higher the score, the better is the related motor function.
Change in Modified Ashworth Scale after training
Time frame: 1) up to 7 weeks, 2) 3 months after participants finish the training
The Modified Ashworth Scale measures the resistance of a joint during passive motion, which indicates the muscle spasticity related to the joint motion, particularly the flexors. The Modified Ashworth Scale has six levels, i.e., 0, 1, 1+, 2, 3, 4. The higher value is related to a higher joint resistance, i.e., higher muscle spasticity.
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 21 Sep 2026.
- Derived from this study: PubMed 41731569Tan F, Qing W, Ip WC, Guo Z, Li Z, Zhang S, Hu X. Guided corticomuscular neuroplasticity for restoration of wrist-hand function post-stroke. J Neuroeng Rehabil. 2026 Feb 23;23(1):105. doi: 10.1186/s12984-026-01915-w.
- Derived from this study: PubMed 35193124Guo Z, Zhou S, Ji K, Zhuang Y, Song J, Nam C, Hu X, Zheng Y. Corticomuscular integrated representation of voluntary motor effort in robotic control for wrist-hand rehabilitation after stroke. J Neural Eng. 2022 Mar 9;19(2). doi: 10.1088/1741-2552/ac5757.
- Derived from this study: PubMed 34335219Ye F, Yang B, Nam C, Xie Y, Chen F, Hu X. A Data-Driven Investigation on Surface Electromyography Based Clinical Assessment in Chronic Stroke. Front Neurorobot. 2021 Jul 15;15:648855. doi: 10.3389/fnbot.2021.648855. eCollection 2021.
- Derived from this study: PubMed 31159822Qian Q, Nam C, Guo Z, Huang Y, Hu X, Ng SC, Zheng Y, Poon W. Distal versus proximal - an investigation on different supportive strategies by robots for upper limb rehabilitation after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2019 Jun 3;16(1):64. doi: 10.1186/s12984-019-0537-5.
- Derived from this study: PubMed 29312116Nam C, Rong W, Li W, Xie Y, Hu X, Zheng Y. The Effects of Upper-Limb Training Assisted with an Electromyography-Driven Neuromuscular Electrical Stimulation Robotic Hand on Chronic Stroke. Front Neurol. 2017 Dec 14;8:679. doi: 10.3389/fneur.2017.00679. eCollection 2017.
- Derived from this study: PubMed 28928706Qian Q, Hu X, Lai Q, Ng SC, Zheng Y, Poon W. Early Stroke Rehabilitation of the Upper Limb Assisted with an Electromyography-Driven Neuromuscular Electrical Stimulation-Robotic Arm. Front Neurol. 2017 Sep 4;8:447. doi: 10.3389/fneur.2017.00447. eCollection 2017.
- Derived from this study: PubMed 28446181Rong W, Li W, Pang M, Hu J, Wei X, Yang B, Wai H, Zheng X, Hu X. A Neuromuscular Electrical Stimulation (NMES) and robot hybrid system for multi-joint coordinated upper limb rehabilitation after stroke. J Neuroeng Rehabil. 2017 Apr 26;14(1):34. doi: 10.1186/s12984-017-0245-y.
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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. This study is not recruiting at the moment.
Xiaoling Hu, Ph.D. principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation; Rehabilitation Robot in people with Stroke, 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 5 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment Scale after training (time frame: 1) up to 7 weeks, 2) 3 months after participants finish the training). The study lists 2 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 NCT02117089, which also lists 7 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 21 Sep 2026.