Repetitive Peripheral Magnetic Stimulation Enhances Modified Constraint-Induced Movement Therapy Outcomes After Stroke
24 kwietnia 2026 zaktualizowane przez: 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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
50
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Jilin
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Changchun, Jilin, Chiny, 130000
- The First Hospital of Jilin University
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
This study included adult patients with post-stroke hemiplegia and upper limb motor impairment receiving rehabilitation treatment.
Opis
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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Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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Experimental group
rPMS+m-CIMT
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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.
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.
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Control group
m-CIMT
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Fugl-Meyer Assessment for Upper Extremity
Ramy czasowe: At baseline and immediately after the 4-week intervention.
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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.
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At baseline and immediately after the 4-week intervention.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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FMA-UE Wrist Subscore
Ramy czasowe: At baseline and immediately after the 4-week intervention.
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This subscale consists of 5 items (items 19-23) assessing wrist stability, extension, flexion, circumduction, and coordination, with a maximum score of 10 points.
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At baseline and immediately after the 4-week intervention.
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Active Range of Motion (AROM) of Wrist Extension
Ramy czasowe: At baseline and immediately after the 4-week intervention.
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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°.
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At baseline and immediately after the 4-week intervention.
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Surface Electromyography (sEMG) of Wrist Extensors
Ramy czasowe: At baseline and immediately after the 4-week intervention.
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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.
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At baseline and immediately after the 4-week intervention.
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Wolf Motor Function Test (WMFT)
Ramy czasowe: At baseline and immediately after the 4-week intervention.
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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.
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At baseline and immediately after the 4-week intervention.
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Motor Activity Log (MAL)
Ramy czasowe: At baseline and immediately after the 4-week intervention.
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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.
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At baseline and immediately after the 4-week intervention.
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Instrumental Activities of Daily Living (IADL) Scale
Ramy czasowe: At baseline and immediately after the 4-week intervention.
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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.
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At baseline and immediately after the 4-week intervention.
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Barthel Index
Ramy czasowe: At baseline and immediately after the 4-week intervention.
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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.
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At baseline and immediately after the 4-week intervention.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Li Zhenlan, phD, The First Hospital of Jilin University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 stycznia 2022
Zakończenie podstawowe (Rzeczywisty)
31 maja 2024
Ukończenie studiów (Rzeczywisty)
31 maja 2024
Daty rejestracji na studia
Pierwszy przesłany
24 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
24 kwietnia 2026
Pierwszy wysłany (Rzeczywisty)
30 kwietnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 kwietnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 kwietnia 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FirstJilinU
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Sharing individual participant data is restricted due to patient privacy protection, confidentiality requirements and institutional ethics committee regulations.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Tak
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .