An interventional study of Active Radial Shockwave and Sham Radial Shockwave in Ischemic Stroke, sponsored by Marta Imamura. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-07.
Sponsored by Marta Imamura · Not applicable, Interventional, and Treatment
This is a double blind randomized clinical trial to evaluate the effect of radial shock waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the territory of the middle cerebral artery. A total of 20 patients will be enrolled and will undergo motor, functional and cortical excitability evaluations before and after four weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air pressure will be applied to the active group, resulting in an energy flux density (EFD) of approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the fact that no energy flux will be applied.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Marta Imamura is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Every patient will receive 5,000 continuous pulses per treatment session, at 3.5 to 4 bar air pressure (resulting in an energy flux density \[EFD\] of approximately 0.07 mJ/mm2) and at 15Hz frequency. A total of 4 sessions will be performed.
Device: Active Radial Shockwave
Every patient will receive 5,000 continuous pulses per treatment session, without air pressure (resulting in no EFD) and at 15Hz frequency. A total of 4 sessions will be performed.
Device: Sham Radial Shockwave
Four weekly sessions of active radial shockwave treatment.
Four weekly sessions of sham radial shockwave treatment.
Fugl-Meyer Assessment (FMA)
Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline.
Time frame: Change from baseline to 8 weeks
Visual Analogue Scale (VAS)
Multiple changes in VAS
Time frame: Baseline, one and two months
Esthesiometry - Von Frey Scale
Multiple changes in Von Frey Scale
Time frame: Baseline, one and two months
Upper Limb Modified Ashworth Scale (MAS)
Multiple changes in MAS
Time frame: Baseline, one week, two weeks, three weeks, four weeks and two months
Fugl-Meyer Assessment
Changes in Fugl-Meyer Assessment compared to baseline
Time frame: Baseline and two months
Medical Research Council scale (MRC)
Multiple changes in MRC scale
Time frame: Baseline, one and two months
Hand grip
Multiple changes in Hand grip
Time frame: Baseline, one and two months
Change in fine motor function measured with Finger Tapping (FT)
Multiple changes in FT
Time frame: Baseline, one and two months
Jebsen-Taylor Hand Function Test (JTHFT)
Multiple changes in JTHFT
Time frame: Baseline, one and two months
Purdue Pegboard Test (PPBT)
Multiple changes in PPBT
Time frame: Baseline, one and two months
Robotic kinematic evaluation (RKE)
Multiple changes in RKE
Time frame: Baseline, one and two months
Corticospinal excitability measures with transcranial magnetic stimulation (TMS)
Multiple changes in Corticospinal excitability
Time frame: Baseline, one and two months
Pinch strength testing
Pinch strength testing
Time frame: Baseline, one and two months
Adverse Events (AE)
Accountability of occurences of Adverse Events
Time frame: Weekly for two months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Marta Imamura