StrokeNCT07559747
Repetitive Peripheral Magnetic Stimulation Enhances Modified Constraint-Induced Movement Therapy Outcomes After Stroke
An observational study of Stroke, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This is a retrospective observational study to investigate the effect of repetitive peripheral magnetic stimulation (rPMS) combined with modified constraint-induced movement therapy (m-CIMT) on upper extremity and finger fine motor function in patients with stroke hemiplegia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- rPMS and m-CIMT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 May 2024
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included adult patients with post-stroke hemiplegia and upper limb motor impairment receiving rehabilitation treatment.
Inclusion Criteria: (1) first-ever ischemic or hemorrhagic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI); (2) post-stroke duration≤6 months; (3) aged between 20 and 80 years; (4) clinically diagnosed with unilateral upper extremity hemiparesis; (5) baseline active wrist extension≥20°, and active extension≥10° in the thumb and at least two additional fingers, as per the modified Constraint-Induced Movement Therapy (m-CIMT) criteria; (6) Brunnstrom stage of the affected upper extremity≥IV; (7) Modified Ashworth Scale (MAS) score of the wrist and finger flexors≤1+; (8) Mini-Mental State Examination (MMSE) score≥21 points; (9) sitting balance≥level 2; (10) had complete medical records documenting receipt of either repetitive peripheral magnetic stimulation (rPMS) priming combined with m-CIMT (experimental group) or m-CIMT alone (control group) for at least 4 consecutive weeks, with treatment sessions conducted once daily, 5 days per week; (11) no concurrent participation in other interventional studies or receipt of other neuromodulation therapies during the study period.
Exclusion Criteria:(1) severe pre-stroke neurological, orthopedic, or rheumatologic conditions affecting upper extremity function; (2) severe joint pain or contracture limiting wrist movement; (3) complications with severe cardiac, pulmonary, hepatic, renal, or infectious diseases; (4) history of epilepsy or seizure disorders; (5) presence of metal implants, cardiac pacemakers, or open wounds at the stimulation site; (6) severe visual impairment affecting task performance; (7) severe depression or psychiatric disorders; (8) pregnancy or lactation; (9) incomplete baseline or post-treatment assessment data.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Priming Wrist Extension With Repetitive Peripheral Magnetic Stimulation Enhances Modified Constraint-Induced Movement Therapy Outcomes After Stroke: A Retrospective Cohort Study
This is a retrospective observational study to investigate the effect of repetitive peripheral magnetic stimulation (rPMS) combined with modified constraint-induced movement therapy (m-CIMT) on upper extremity and finger fine motor function in patients with stroke hemiplegia. We hypothesize that rPMS priming immediately before m-CIMT can enhance wrist extensor activation during task practice and lead to better upper limb motor recovery than m-CIMT alone. Outcome measures include joint range of motion, muscle tone, grip strength, upper limb motor function, and activities of daily living.
Read the detailed description
Modified constraint-induced movement therapy (m-CIMT) is an evidence-based intervention for post-stroke upper limb rehabilitation, yet therapeutic gains are often limited by compensatory wrist flexion. This maladaptive pattern reflects insufficient wrist extensor recruitment and persistent flexor synergy dominance, which biomechanically places finger flexors in an unfavorable length-tension relationship and compromises grasp force generation. Repetitive peripheral magnetic stimulation (rPMS) non-invasively enhances wrist extensor excitability and exerts priming effects on sensorimotor pathways. We hypothesized that rPMS priming immediately prior to m-CIMT would facilitate wrist extensor engagement during task practice and produce superior upper limb motor recovery compared with m-CIMT alone.
- Conditions
- Stroke
- Being tested
- rPMS, m-CIMT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPMSDevice
rPMS was administered using a pulsed magnetic field stimulator (M-100 Ultimate, Shenzhen Yingchi Technology Co., Ltd., China) with a circular stimulation coil (OY120A, diameter 120 mm). The patient was seated with the affected upper limb positioned on a treatment table, shoulder abducted to 90°, elbow flexed to 90°, forearm pronated, and wrist in a neutral position over the table edge. The stimulation coil was placed over the motor point of the radial nerve, approximately 5-7 cm proximal to the wrist joint on the dorsal forearm. The optimal stimulation site was determined by identifying the location that produced the most robust wrist extension movement when single pulses were delivered.
m-CIMTBehavioural
The intervention comprised restraint of the unaffected upper extremity and repetitive, task-oriented practice with the affected upper extremity using shaping techniques. Functional tasks were selected from a standardized task database based on individual patient needs and baseline motor function. Tasks were graded to be slightly above the patient's current ability level. Each task was practiced for 30-120s per trial for 10 repetitions. Therapists provided verbal encouragement, performance feedback, and physical guidance as needed. The training intervention was 90min per session, once a day, 5 days a week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | rPMS+m-CIMT Receives: Device: rPMS; Behavioral: m-CIMT | |
| Control group | m-CIMT Receives: Behavioral: m-CIMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity
A validated 33-item measure assessing motor impairment of the upper limb following stroke. The FMA-UE evaluates reflex activity, voluntary movement control of the shoulder, elbow, forearm, wrist, and hand, as well as coordination and speed. Each item is scored on a 3-point ordinal scale (0=cannot perform, 1=performs partially, 2=performs fully), with a total possible score of 66 points. Higher scores indicate better motor function.
Measured: At baseline and immediately after the 4-week intervention.
Secondary outcomes (7)
FMA-UE Wrist Subscore
This subscale consists of 5 items (items 19-23) assessing wrist stability, extension, flexion, circumduction, and coordination, with a maximum score of 10 points.
Measured: At baseline and immediately after the 4-week intervention.
Active Range of Motion (AROM) of Wrist Extension
AROM was measured using a goniometer with standardized positioning: patient seated, shoulder abducted to 90°, elbow flexed to 90°, forearm pronated, and wrist positioned over the table edge. The stationary arm of the goniometer was aligned with the lateral midline of the forearm, and the movable arm was aligned with the dorsal midline of the third metacarpal. The axis was placed over the ulnar styloid process. From a neutral starting position (0°), patients were instructed to actively extend the wrist as far as possible. The measurement was repeated three times, and the average value was recorded. Normal wrist extension AROM ranges from 0° to 70°.
Measured: At baseline and immediately after the 4-week intervention.
Surface Electromyography (sEMG) of Wrist Extensors
sEMG was recorded from the paretic extensor carpi radialis (ECR) using a wireless system (SG-800B, Dinovo Medical Technology, China) with bipolar Ag/AgCl electrodes (inter-electrode distance: 20 mm). Following SENIAM guidelines for electrode placement and standardized skin preparation, participants performed maximal voluntary isometric contraction (MVIC) of wrist extension against manual resistance, sustained for 5 seconds and repeated three times with 60-second rest intervals. Signals were sampled at 2000Hz, band-pass filtered (20-450Hz), notch-filtered at 50Hz, and full-wave rectified. sEMG outcomes included Average EMG amplitude (AEMG, μV) during the stable phase of MVIC (middle 3 seconds) and Root mean square (RMS, μV) amplitude.
Measured: At baseline and immediately after the 4-week intervention.
Wolf Motor Function Test (WMFT)
The WMFT is a standardized, timed performance-based assessment consisting of 17 items: 15 timed functional tasks and 2 strength measures. The timed tasks assess the ability to perform functional movements such as lifting cans, turning a key, and stacking checkers. Performance is quantified by: (a) WMFT-Time: the time to complete each task (capped at 120 seconds), with lower scores indicating better performance; (b) WMFT-Score: a functional ability score rated on a 6-point ordinal scale (0=no use to 5=normal use), with a maximum total score of 75 points. The grip strength item (Item 14) was measured using a Jamar dynamometer (Sammons Preston, USA) according to American Society of Hand Therapists (ASHT) standards, with the mean of three trials recorded.
Measured: At baseline and immediately after the 4-week intervention.
Motor Activity Log (MAL)
The MAL is a structured interview assessing the patient's self-reported use of the affected upper limb in real-world activities. The MAL consists of 30 standardized questions evaluating the amount of use (Amount of Use scale, AOU) and quality of movement (How Well scale, HW) during daily tasks. Each item is scored on a 6-point scale (0-5), with total scores ranging from 0 to 150 for each subscale. Higher scores indicate greater frequency and quality of affected limb use.
Measured: At baseline and immediately after the 4-week intervention.
Instrumental Activities of Daily Living (IADL) Scale
The IADL scale assesses the ability to perform complex daily tasks requiring higher-level cognitive and motor function, including telephone use, shopping, food preparation, housekeeping, laundry, transportation, medication management, and financial management. The scale consists of 8 items scored from 0 (unable) to 3 (independent), with a maximum score of 24 points.
Measured: At baseline and immediately after the 4-week intervention.
Barthel Index
The BI is a widely used 10-item measure assessing basic activities of daily living, including bowel and bladder control, feeding, grooming, dressing, transfers, mobility, and stair climbing. Total scores range from 0 to 100, with higher scores indicating greater independence.
Measured: At baseline and immediately after the 4-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jan 2022
- Primary completion31 May 2024
- Study completion31 May 2024
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.
- More trials run by The First Hospital of Jilin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Zhenlan, phD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559747
- Sponsor's protocol ID
- FirstJilinU
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Sharing individual participant data is restricted due to patient privacy protection, confidentiality requirements and institutional ethics committee regulations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priming Wrist Extension With Repetitive Peripheral Magnetic Stimulation Enhances Modified Constraint-Induced Movement Therapy Outcomes After Stroke: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07559747
- Acronym / sponsor ID
- FirstJilinU
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 30 Apr 2026 (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.
This is a retrospective observational study to investigate the effect of repetitive peripheral magnetic stimulation (rPMS) combined with modified constraint-induced movement therapy (m-CIMT) on upper extremity and finger fine motor function in patients with stroke hemiplegia. We hypothesize that rPMS priming immediately before m-CIMT can enhance wrist extensor activation during task practice and lead to better upper limb motor recovery than m-CIMT alone. Outcome measures include joint range of motion, muscle tone, grip strength, upper limb motor function, and activities of daily living.
Detailed description
Modified constraint-induced movement therapy (m-CIMT) is an evidence-based intervention for post-stroke upper limb rehabilitation, yet therapeutic gains are often limited by compensatory wrist flexion. This maladaptive pattern reflects insufficient wrist extensor recruitment and persistent flexor synergy dominance, which biomechanically places finger flexors in an unfavorable length-tension relationship and compromises grasp force generation. Repetitive peripheral magnetic stimulation (rPMS) non-invasively enhances wrist extensor excitability and exerts priming effects on sensorimotor pathways. We hypothesized that rPMS priming immediately prior to m-CIMT would facilitate wrist extensor engagement during task practice and produce superior upper limb motor recovery compared with m-CIMT alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Device: rPMS, Behavioral: m-CIMTrPMS+m-CIMT |
| Control group | – | Behavioral: m-CIMTm-CIMT |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included adult patients with post-stroke hemiplegia and upper limb motor impairment receiving rehabilitation treatment.
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 |
|---|---|---|
| rPMSrPMS was administered using a pulsed magnetic field stimulator (M-100 Ultimate, Shenzhen Yingchi Technology Co., Ltd., China) with a circular stimulation coil (OY120A, diameter 120 mm). The patient was seated with the affected upper limb positioned on a treatment table, shoulder abducted to 90°, elbow flexed to 90°, forearm pronated, and wrist in a neutral position over the table edge. The stimulation coil was placed over the motor point of the radial nerve, approximately 5-7 cm proximal to the wrist joint on the dorsal forearm. The optimal stimulation site was determined by identifying the location that produced the most robust wrist extension movement when single pulses were delivered. | Device | Experimental group |
| m-CIMTThe intervention comprised restraint of the unaffected upper extremity and repetitive, task-oriented practice with the affected upper extremity using shaping techniques. Functional tasks were selected from a standardized task database based on individual patient needs and baseline motor function. Tasks were graded to be slightly above the patient's current ability level. Each task was practiced for 30-120s per trial for 10 repetitions. Therapists provided verbal encouragement, performance feedback, and physical guidance as needed. The training intervention was 90min per session, once a day, 5 days a week, for 4 weeks. | Behavioural | Control group, Experimental group |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity
Time frame: At baseline and immediately after the 4-week intervention.
A validated 33-item measure assessing motor impairment of the upper limb following stroke. The FMA-UE evaluates reflex activity, voluntary movement control of the shoulder, elbow, forearm, wrist, and hand, as well as coordination and speed. Each item is scored on a 3-point ordinal scale (0=cannot perform, 1=performs partially, 2=performs fully), with a total possible score of 66 points. Higher scores indicate better motor function.
7 secondary outcomes
FMA-UE Wrist Subscore
Time frame: At baseline and immediately after the 4-week intervention.
Active Range of Motion (AROM) of Wrist Extension
Time frame: At baseline and immediately after the 4-week intervention.
Surface Electromyography (sEMG) of Wrist Extensors
Time frame: At baseline and immediately after the 4-week intervention.
Wolf Motor Function Test (WMFT)
Time frame: At baseline and immediately after the 4-week intervention.
Motor Activity Log (MAL)
Time frame: At baseline and immediately after the 4-week intervention.
Instrumental Activities of Daily Living (IADL) Scale
Time frame: At baseline and immediately after the 4-week intervention.
Barthel Index
Time frame: At baseline and immediately after the 4-week intervention.
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 30 Apr 2026.
- Individual participant dataSharing planned: No. Sharing individual participant data is restricted due to patient privacy protection, confidentiality requirements and institutional ethics committee regulations.
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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.
Li Zhenlan, phD principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by The First Hospital of Jilin 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?
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 30 Apr 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?
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?
Fugl-Meyer Assessment for Upper Extremity (time frame: At baseline and immediately after the 4-week intervention.). 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 30 Apr 2026.