AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

-

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

Other trials in China

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 groups in NCT07559747
Study groupRoleWhat they receive
Experimental grouprPMS+m-CIMT
Receives: Device: rPMS; Behavioral: m-CIMT
Control groupm-CIMT
Receives: Behavioral: m-CIMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  1. First posted30 Apr 2026
  2. Study start1 Jan 2022
  3. Primary completion31 May 2024
  4. Study completion31 May 2024

Resources

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)
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.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in