Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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) |
Device: 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)
Other: physical therapy
regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)
|
| Placebo Comparator: physical therapy only regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day) |
Other: physical therapy
regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)
|
Outcome Measures
Primary Outcome Measures
- pain [0,7, 14,28 days]
change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)
Secondary Outcome Measures
- strength of upper limb [0,7, 14,28 days]
change of score of Manual muscle testing (0-5, higher scores mean a better outcome)
- spasticity of upper limb [0,7, 14,28 days]
change of Modified Ashworth Scale (0-4, higher scores mean a worse outcome)
- range of motion of shoulder [0,7, 14,28 days]
Change in range of motion in degree in flexion, extension, abduction, external and internal rotation (0-180 degrees,higher scores mean a better outcome)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Ming Yen Y Hsiao, MDPHD, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202105016RIPB