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Repetitive Peripheral Magnetic Stimulation Enhances Modified Constraint-Induced Movement Therapy Outcomes After Stroke

24 aprile 2026 aggiornato da: The First Hospital of Jilin University

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

50

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Jilin
      • Changchun, Jilin, Cina, 130000
        • The First Hospital of Jilin University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

This study included adult patients with post-stroke hemiplegia and upper limb motor impairment receiving rehabilitation treatment.

Descrizione

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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Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Experimental group
rPMS+m-CIMT
Dispositivo: rPMS
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.
Comportamentale: m-CIMT
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.
Control group
m-CIMT
Comportamentale: m-CIMT
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fugl-Meyer Assessment for Upper Extremity
Lasso di tempo: 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.
At baseline and immediately after the 4-week intervention.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
FMA-UE Wrist Subscore
Lasso di tempo: At baseline and immediately after the 4-week intervention.
This subscale consists of 5 items (items 19-23) assessing wrist stability, extension, flexion, circumduction, and coordination, with a maximum score of 10 points.
At baseline and immediately after the 4-week intervention.
Active Range of Motion (AROM) of Wrist Extension
Lasso di tempo: At baseline and immediately after the 4-week intervention.
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°.
At baseline and immediately after the 4-week intervention.
Surface Electromyography (sEMG) of Wrist Extensors
Lasso di tempo: At baseline and immediately after the 4-week intervention.
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.
At baseline and immediately after the 4-week intervention.
Wolf Motor Function Test (WMFT)
Lasso di tempo: At baseline and immediately after the 4-week intervention.
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.
At baseline and immediately after the 4-week intervention.
Motor Activity Log (MAL)
Lasso di tempo: At baseline and immediately after the 4-week intervention.
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.
At baseline and immediately after the 4-week intervention.
Instrumental Activities of Daily Living (IADL) Scale
Lasso di tempo: At baseline and immediately after the 4-week intervention.
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.
At baseline and immediately after the 4-week intervention.
Barthel Index
Lasso di tempo: At baseline and immediately after the 4-week intervention.
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.
At baseline and immediately after the 4-week intervention.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The First Hospital of Jilin University

Investigatori

  • Investigatore principale: Li Zhenlan, phD, The First Hospital of Jilin University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2022

Completamento primario (Effettivo)

31 maggio 2024

Completamento dello studio (Effettivo)

31 maggio 2024

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

30 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 aprile 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FirstJilinU

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Sharing individual participant data is restricted due to patient privacy protection, confidentiality requirements and institutional ethics committee regulations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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