An interventional study of peripheral magnetic stimulation and physical therapy in Reflex Sympathetic Dystrophy of Upper Limb and Stroke, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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 · Other: physical therapy
regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)
Other: physical therapy
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)
regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)
pain
change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)
Time frame: 0,7, 14,28 days
strength of upper limb
change of score of Manual muscle testing (0-5, higher scores mean a better outcome)
Time frame: 0,7, 14,28 days
spasticity of upper limb
change of Modified Ashworth Scale (0-4, higher scores mean a worse outcome)
Time frame: 0,7, 14,28 days
range of motion of shoulder
Change in range of motion in degree in flexion, extension, abduction, external and internal rotation (0-180 degrees,higher scores mean a better outcome)
Time frame: 0,7, 14,28 days
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital