StrokeNCT06367140
Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke
A study testing EMG-triggered CIMCT device and general cycling training in people with Stroke, run by Sahmyook University at 1 site in South Korea.
Trial summary
The study investigates the potential of Electromyography (EMG)-triggered Constraint-Induced Movement Cycling Therapy (CIMCT) versus General Cycling Training (GCT) to enhance balance, strength, and daily activities in chronic stroke patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- EMG-triggered CIMCT device and general cycling training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with chronic stroke-induced hemiplegia
- Diagnosed with stroke for more than 6 months
- Achieving a minimum score of 24 points on the Mini-Mental State Examination
- Demonstrating motor recovery at or above level 3 according to the Brunnstrom stages
Who cannot join
- Individuals with neurological damage unrelated to their stroke
- Orthopedic issues such as fractures or peripheral nervous system damage in the lower limbs
- Visual or auditory impairments
- Those who had experienced more than one stroke
- Those with less than an 80% participation rate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Physicla Therapy, Sahmyook University
Seoul, 01795
About this study
Official title: Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke: A Randomized Controlled Trial
The study investigates the potential of Electromyography (EMG)-triggered Constraint-Induced Movement Cycling Therapy (CIMCT) versus General Cycling Training (GCT) to enhance balance, strength, and daily activities in chronic stroke patients. Over a period of four weeks, this single-blind randomized controlled trial aims to explore how these interventions can assist in stroke rehabilitation. The research has been approved by the Ethics Committee of Kyungdong University and adheres to the ethical standards laid out in the Declaration of Helsinki.
Read the detailed description
This research evaluates the effectiveness of EMG-triggered CIMCT in improving balance, lower extremity strength, and activities of daily living (ADLs) for chronic stroke patients with hemiplegia, a condition typically resulting from a stroke. The study's scope includes:
Duration and Type: A four-week, single-blind randomized controlled trial. Participants: Chronic stroke patients diagnosed with stroke-induced hemiplegia for more than six months, possessing specific levels of cognitive and motor recovery.
Interventions: Participants are randomly assigned to one of two groups:
CIMCT Group: Utilizes an EMG-triggered Constraint-Induced Movement Therapy device designed to engage the affected lower extremity actively.
GCT Group: Engages in activity using a standard stationary bicycle without EMG facilitation.
- Conditions
- Stroke
- Being tested
- EMG-triggered CIMCT device, general cycling training
- Keywords
- Postural balance, Electromyography, Muscle Strength, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG-triggered CIMCT deviceDevice
The study tested an EMG-triggered CIMCT device for stroke rehab, involving EMG sensors, a stationary bike, and a control unit displaying muscle activity. The protocol included warm-up, therapist-guided exercises, and cool-down, performed under supervision.
general cycling trainingDevice
The training aimed to improve overall physical fitness and potentially aid in stroke recovery through regular cycling activity, conducted under supervision to ensure participant safety and adherence to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| constraint-induced movement therapy groups | Experimental | The device utilized EMG sensors to collect signals from the leg muscles, which then controlled the cycling motion. This group underwent specific training sessions designed to enhance muscle activation on the affected side by inducing voluntary contractions through cycling, with the aim of improving muscle strength, balance, and activities of daily living. The sessions included a structured regimen of warm-up, active cycling with therapist-guided acceleration based on muscle activation, and cool-down periods, conducted under supervision for safety and effectiveness. Receives: Device: EMG-triggered CIMCT device |
| general cycling training groups | Sham comparator | This group followed a similar session structure to the CIMCT group, including warm-up, cycling at a comfortable pace, and cool-down phases, but without the targeted muscle activation component. Receives: Device: general cycling training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
A manual muscle tester (Model 01163, Lafayette, USA, 2003) was used to evaluate lower extremity muscle strength in this study. The knee extensors, knee flexors, dorsiflexors, and plantar flexors, which are primarily responsible for the pedaling motion, were assessed. Moreover, both sides were evaluated.
Measured: baseline-4weeks
Static Balance
This study utilized a commercially available GB300 (Metitur Ltd., Jyvaskyla, Finland) posture measurement system for posture measurement, which included a movable triangular-shaped platform and a ruler that displayed the position of the feet. The aforementioned system was useful for analyzing balance problems and the effectiveness of rehabilitation. The posture management system is also commonly used to assess balance ability in athletes, older individuals, patients with stroke, and patients with hemiplegia. The sampling frequency was set at 50 Hz. The participants stood with their eyes open and facing forward for 30 s while fixed to the equipment; this was repeated three times. Subsequently, they stood in the same position with their eyes closed and facing forward for 30 s for three additional measurements.
Measured: baseline-4weeks
Timed Up and Go (TUG)
The Timed up-and-go (TUG) test was used to assess the balance ability in this study. In the test, the participant sits in a chair with armrests, rises from the chair at the same time as the word "start" is spoken, walks at the most stable and comfortable speed to a point 3 m in front of them, and then returns and measures the time to sit down in the chair. It has a high intra-rater reliability (r=.99) and inter-rater reliability (r=.98). The raters performed three measurements using a stopwatch and recorded the average value.
Measured: baseline-4weeks
Berg Balance Scale
The Berg Balance Scale is used to assess functional balance in a wide range of participants, including older individuals at a high risk of falling and patients with acute and chronic diseases. Moreover, Berg Balance Scale is a functional balance test method that considers three aspects of functional balance: postural maintenance, postural control by manual exercise, and response to external perturbations. these activities are scored from 0 to 4, with 0 being the worst and 4 being the best performance of independent tasks. The maximum total score is 56 points. A lower score suggests impaired stability.
Measured: baseline-4weeks
Functional Reach Test (FRT)
The functional reach test (FRT) assesses the limits of physical stability and measures dynamic balance and flexibility while the participant performs a functional task. The FRT measures the maximum distance a participant can extend their arm forward from a standing position while maintaining fixed support. The distance was measured in centimeters using a Laser Rangefinder (DLE50, BOSCH, Germany). The results represented the averages of three consecutive measurements. The reliability of this test was 0.89.
Measured: baseline-4weeks
Modified Barthel Index (MBI)
The modified Barthel index (MBI) developed by was used to measure the performance of daily living behaviors. The MBI consists of 10 items: self-care, bathing, feeding, climbing stairs, dressing, bowel control, bladder control, walking, and transferring. The scoring system ranged from 5 to 15, with a score of 100 if all items could be performed completely independently. The inter-rater reliability was 0.93-0.98, and the Cronbach's alpha value was 0.84.
Measured: baseline-4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Kyungdong University
- Responsible party
- Principal investigator, Changho Song, Sahmyook University
- Investigators
- Jaemyoung Park, Ph.D., Study chair, Sahmyook UniversityJung hyun Kim, prof, Study director, Seoul National University HospitalKyeongjin Lee, prof, Study director, Kyungdong UniversityChangho Song, prof, Principal investigator, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367140
- Sponsor's protocol ID
- SYU 2021-06-001-002
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06367140
- Acronym / sponsor ID
- SYU 2021-06-001-002
- Conditions
- Stroke
- Keywords
- Postural balance, Electromyography, Muscle Strength, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Kyungdong University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Apr 2024 (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 study investigates the potential of Electromyography (EMG)-triggered Constraint-Induced Movement Cycling Therapy (CIMCT) versus General Cycling Training (GCT) to enhance balance, strength, and daily activities in chronic stroke patients. Over a period of four weeks, this single-blind randomized controlled trial aims to explore how these interventions can assist in stroke rehabilitation. The research has been approved by the Ethics Committee of Kyungdong University and adheres to the ethical standards laid out in the Declaration of Helsinki.
Detailed description
This research evaluates the effectiveness of EMG-triggered CIMCT in improving balance, lower extremity strength, and activities of daily living (ADLs) for chronic stroke patients with hemiplegia, a condition typically resulting from a stroke. The study's scope includes:
Duration and Type: A four-week, single-blind randomized controlled trial. Participants: Chronic stroke patients diagnosed with stroke-induced hemiplegia for more than six months, possessing specific levels of cognitive and motor recovery.
Interventions: Participants are randomly assigned to one of two groups:
CIMCT Group: Utilizes an EMG-triggered Constraint-Induced Movement Therapy device designed to engage the affected lower extremity actively.
GCT Group: Engages in activity using a standard stationary bicycle without EMG facilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| constraint-induced movement therapy groups | Experimental | Device: EMG-triggered CIMCT deviceThe device utilized EMG sensors to collect signals from the leg muscles, which then controlled the cycling motion. This group underwent specific training sessions designed to enhance muscle activation on the affected side by inducing voluntary contractions through cycling, with the aim of improving muscle strength, balance, and activities of daily living. The sessions included a structured regimen of warm-up, active cycling with therapist-guided acceleration based on muscle activation, and cool-down periods, conducted under supervision for safety and effectiveness. |
| general cycling training groups | Sham comparator | Device: general cycling trainingThis group followed a similar session structure to the CIMCT group, including warm-up, cycling at a comfortable pace, and cool-down phases, but without the targeted muscle activation component. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic stroke-induced hemiplegia
- Diagnosed with stroke for more than 6 months
- Achieving a minimum score of 24 points on the Mini-Mental State Examination
- Demonstrating motor recovery at or above level 3 according to the Brunnstrom stages
Key exclusion criteria (5 listed)
- Individuals with neurological damage unrelated to their stroke
- Orthopedic issues such as fractures or peripheral nervous system damage in the lower limbs
- Visual or auditory impairments
- Those who had experienced more than one stroke
- Those with less than an 80% participation rate in the study
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 |
|---|---|---|
| EMG-triggered CIMCT deviceThe study tested an EMG-triggered CIMCT device for stroke rehab, involving EMG sensors, a stationary bike, and a control unit displaying muscle activity. The protocol included warm-up, therapist-guided exercises, and cool-down, performed under supervision. | Device | constraint-induced movement therapy groups |
| general cycling trainingThe training aimed to improve overall physical fitness and potentially aid in stroke recovery through regular cycling activity, conducted under supervision to ensure participant safety and adherence to the protocol. | Device | general cycling training groups |
Primary outcome
Muscle Strength
Time frame: baseline-4weeks
A manual muscle tester (Model 01163, Lafayette, USA, 2003) was used to evaluate lower extremity muscle strength in this study. The knee extensors, knee flexors, dorsiflexors, and plantar flexors, which are primarily responsible for the pedaling motion, were assessed. Moreover, both sides were evaluated.
Static Balance
Time frame: baseline-4weeks
This study utilized a commercially available GB300 (Metitur Ltd., Jyvaskyla, Finland) posture measurement system for posture measurement, which included a movable triangular-shaped platform and a ruler that displayed the position of the feet. The aforementioned system was useful for analyzing balance problems and the effectiveness of rehabilitation. The posture management system is also commonly used to assess balance ability in athletes, older individuals, patients with stroke, and patients with hemiplegia. The sampling frequency was set at 50 Hz. The participants stood with their eyes open and facing forward for 30 s while fixed to the equipment; this was repeated three times. Subsequently, they stood in the same position with their eyes closed and facing forward for 30 s for three additional measurements.
Timed Up and Go (TUG)
Time frame: baseline-4weeks
The Timed up-and-go (TUG) test was used to assess the balance ability in this study. In the test, the participant sits in a chair with armrests, rises from the chair at the same time as the word "start" is spoken, walks at the most stable and comfortable speed to a point 3 m in front of them, and then returns and measures the time to sit down in the chair. It has a high intra-rater reliability (r=.99) and inter-rater reliability (r=.98). The raters performed three measurements using a stopwatch and recorded the average value.
Berg Balance Scale
Time frame: baseline-4weeks
The Berg Balance Scale is used to assess functional balance in a wide range of participants, including older individuals at a high risk of falling and patients with acute and chronic diseases. Moreover, Berg Balance Scale is a functional balance test method that considers three aspects of functional balance: postural maintenance, postural control by manual exercise, and response to external perturbations. these activities are scored from 0 to 4, with 0 being the worst and 4 being the best performance of independent tasks. The maximum total score is 56 points. A lower score suggests impaired stability.
Functional Reach Test (FRT)
Time frame: baseline-4weeks
The functional reach test (FRT) assesses the limits of physical stability and measures dynamic balance and flexibility while the participant performs a functional task. The FRT measures the maximum distance a participant can extend their arm forward from a standing position while maintaining fixed support. The distance was measured in centimeters using a Laser Rangefinder (DLE50, BOSCH, Germany). The results represented the averages of three consecutive measurements. The reliability of this test was 0.89.
Modified Barthel Index (MBI)
Time frame: baseline-4weeks
The modified Barthel index (MBI) developed by was used to measure the performance of daily living behaviors. The MBI consists of 10 items: self-care, bathing, feeding, climbing stairs, dressing, bowel control, bladder control, walking, and transferring. The scoring system ranged from 5 to 15, with a score of 100 if all items could be performed completely independently. The inter-rater reliability was 0.93-0.98, and the Cronbach's alpha value was 0.84.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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.
Jaemyoung Park, Ph.D. study chair
Sahmyook University
Jung hyun Kim, prof study director
Seoul National University Hospital
Kyeongjin Lee, prof study director
Kyungdong 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 EMG-triggered CIMCT device and general cycling training in people with Stroke, run by Sahmyook University at 1 site in South Korea.
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 5 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: finished, as of the sponsor's last update on 17 Apr 2024. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle Strength (time frame: baseline-4weeks). The study lists 6 primary outcomes in all. 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 17 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.