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Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome

NCT ID: NCT05112094

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-06-30

Brief Summary

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Shoulder-hand syndrome is a common complication following stroke, constituting of excessive pain, swelling, heat, limited range of motion, and trophic change of the affected limbs. It not only has an extensive negative impact on both physical and psychological aspects of a stroke patient's well-being, but also impose burden on the health care system and the patient's family. Despite its relatively high incidence, there is neither well-established treatment protocol, nor high quality evidence for a single effective treatment. The objective of the present study is to investigate the efficacy, including pain, spasticity, and subluxation reduction, muscle strengthening, and shoulder range of motion improvement, of high-intensity peripheral magnetic stimulation generated by the super-inductive system to treat patients with post-stroke shoulder-hand syndrome.

Detailed Description

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The present study aims to investigate the therapeutic effects achieved by the peripheral magnetic stimulation for treating post-stroke shoulder-hand syndrome. The investigators plan to use high-intensity peripheral magnetic stimulation generated by the super-inductive system for treatment of post-stroke shoulder-hand syndrome. In terms of study design, the treatment group will receive 10 sessions of high-intensity peripheral magnetic stimulation 5 days a week for 2 weeks, with physical and occupational therapy kept as usual; while the control group will only receive conventional physical and occupational therapy. Comprehensive assessment, including history taking and physical examination testing for muscle strength, spasticity, shoulder range of motion, before and after the intervention will be conducted for evaluation.

Conditions

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Reflex Sympathetic Dystrophy of Upper Limb Stroke

Keywords

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shoulder pain magnetic stimulation electric stimulation reflex sympathetic dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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peripheral magnetic stimulation

peripheral magnetic stimulation (50-80% output, 20-40Hz, pulse duration 3-5 seconds, for 15 minutes) + physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)

Group Type EXPERIMENTAL

peripheral magnetic stimulation

Intervention Type DEVICE

peripheral magnetic stimulation at ipsilateral shoulder ((50-80% output, 20-40Hz, pulse duration 3-5 seconds, for 15 minutes) ) + regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)

physical therapy

Intervention Type OTHER

regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)

physical therapy only

regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)

Group Type PLACEBO_COMPARATOR

physical therapy

Intervention Type OTHER

regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)

Interventions

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peripheral magnetic stimulation

peripheral magnetic stimulation at ipsilateral shoulder ((50-80% output, 20-40Hz, pulse duration 3-5 seconds, for 15 minutes) ) + regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)

Intervention Type DEVICE

physical therapy

regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>=20 years old
* Stroke in recent 6 months
* Clear consciousness
* Clinical diagnosis of post-stroke shoulder-hand syndrome

Exclusion Criteria

* Acute bursitis, tendonitis or tendon tear
* Fracture, dislocation or joint infection within 3 months
* Malignancy at treatment site
* Seizure
* Prosthesis or implant at treatment site
* Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming Yen Y Hsiao, MDPHD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ming Yen Hsiao

Role: CONTACT

Phone: 0972652857

Email: [email protected]

Facility Contacts

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Hsiao Ming Yen, MDPHD

Role: primary

Other Identifiers

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202105016RIPB

Identifier Type: -

Identifier Source: org_study_id