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

NCT07559747 | Completed DMC FDA Device

• 1 other identifier: FirstJilinU
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (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.

  At baseline and immediately after the 4-week intervention.

Secondary Outcomes (7)

• FMA-UE Wrist Subscore

  At baseline and immediately after the 4-week intervention.

• Active Range of Motion (AROM) of Wrist Extension

  At baseline and immediately after the 4-week intervention.

• Surface Electromyography (sEMG) of Wrist Extensors

  At baseline and immediately after the 4-week intervention.

• Wolf Motor Function Test (WMFT)

  At baseline and immediately after the 4-week intervention.

• Motor Activity Log (MAL)

  At baseline and immediately after the 4-week intervention.

Study Arms (2)

Experimental group

rPMS+m-CIMT

Device: rPMS; Behavioral: m-CIMT

Control group

m-CIMT

Behavioral: m-CIMT

Interventions

rPMS DEVICE

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.

Experimental group

m-CIMT BEHAVIORAL

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; Experimental group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Li Zhenlan, phD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: January 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)