StrokeNCT03208439
Neuromuscular Electrical Stimulation Cycling
A study testing lower-limb cycling system in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- lower-limb cycling system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Aug 2017to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
- sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
- significant gait deficit (Functional Ambulatory Category, FAC, scale <4 [person cannot walk independently]).
Who cannot join
- any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression;
- severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
- implanted cardiac device (e.g. pacemaker and internal defibrillator).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Shatin
Raymond Tong, PhD, +852 3943 8454
About this study
Official title: Interactive Cycling System Using Electromyography (EMG)-Driven Neuromuscular Electrical Stimulation (NMES) for Rehabilitation
A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling.
- Conditions
- Stroke
- Being tested
- lower-limb cycling system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower-limb cycling systemDevice
patients will receive 30-minute cycling exercise
| Study group | Role | What they receive |
|---|---|---|
| EMG-driven NMES | Experimental | subjects will receive EMG-driven NMES cycling exercise. Receives: Device: lower-limb cycling system |
| passive pre-programmed NMES | Placebo comparator | subjects will receive passive pre-programmed NMES during cycling exercise. Receives: Device: lower-limb cycling system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower-Extremities Fugl-Meyer Assessment
Measured: 3-month follow up
Secondary outcomes (5)
Elderly Mobility Scale
Measured: 3-month follow up
Berg Balance Scale
Measured: 3-month follow up
6-Minute Walking Test
Measured: 3-month follow up
10-Meter Walk Test
Measured: 3-month follow up
electroencephalography
Measured: 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start10 Aug 2017
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Kai-yu Tong, PhD, Principal investigator, Department of Biomedical Engineering, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208439
- Sponsor's protocol ID
- 2016.093-T
- Status last verified
- Sep 2017
- First submitted
- 3 Jul 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu C, Wang T, Leung KWC, Li L, Tong RK. Muscle Electrical Impedance Properties and Activation Alteration After Functional Electrical Stimulation-Assisted Cycling Training for Chronic Stroke Survivors: A Longitudinal Pilot Study. Front Neurol. 2021 Dec 15;12:746263. doi: 10.3389/fneur.2021.746263. eCollection 2021.
PubMed 34975713
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Cycling System Using Electromyography (EMG)-Driven Neuromuscular Electrical Stimulation (NMES) for Rehabilitation
- ClinicalTrials.gov ID
- NCT03208439
- Acronym / sponsor ID
- 2016.093-T
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Jan 2018 (estimated)
- First posted
- 5 Jul 2017 (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 electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG-driven NMES | Experimental | Device: lower-limb cycling systemsubjects will receive EMG-driven NMES cycling exercise. |
| passive pre-programmed NMES | Placebo comparator | Device: lower-limb cycling systemsubjects will receive passive pre-programmed NMES during cycling exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
- sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
- significant gait deficit (Functional Ambulatory Category, FAC, scale <4 [person cannot walk independently]).
Key exclusion criteria (3 listed)
- any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression;
- severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
- implanted cardiac device (e.g. pacemaker and internal defibrillator).
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 |
|---|---|---|
| lower-limb cycling systempatients will receive 30-minute cycling exercise | Device | EMG-driven NMES, passive pre-programmed NMES |
Primary outcome
Lower-Extremities Fugl-Meyer Assessment
Time frame: 3-month follow up
5 secondary outcomes
Elderly Mobility Scale
Time frame: 3-month follow up
Berg Balance Scale
Time frame: 3-month follow up
6-Minute Walking Test
Time frame: 3-month follow up
10-Meter Walk Test
Time frame: 3-month follow up
electroencephalography
Time frame: 3-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 34975713Hu C, Wang T, Leung KWC, Li L, Tong RK. Muscle Electrical Impedance Properties and Activation Alteration After Functional Electrical Stimulation-Assisted Cycling Training for Chronic Stroke Survivors: A Longitudinal Pilot Study. Front Neurol. 2021 Dec 15;12:746263. doi: 10.3389/fneur.2021.746263. eCollection 2021.
- 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. This study is not recruiting at the moment.
Raymond Kai-yu Tong, PhD principal investigator
Department of Biomedical Engineering, CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lower-limb cycling system in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Sep 2017. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raymond Kai-yu Tong, PhD (+852 3943 8454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower-Extremities Fugl-Meyer Assessment (time frame: 3-month follow up). 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 NCT03208439, which also lists 1 linked publication.
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 Sep 2017.