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van CCT (UK)

van CCT (UK)

The influence of shock wave therapy on function improvement of upper limb muscles after stroke.

- candidate number15516
- NTR NumberNTR4201
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-okt-2013
- Secondary IDsUMO-2011/03/N/NZ7/00327 GR-783/NCN/2012
- Public TitleThe influence of shock wave therapy on function improvement of upper limb muscles after stroke.
- Scientific TitleEvaluation of the impact of extracorporeal shock wave (ESW) stimulation on thermal and electrophysiological phenomena of muscles affected by spasticity after ischemic stroke.
- ACRONYMESW - extracorporeal shock wave
- hypothesisAuthors hypothesized that the physical extracorporeal shock wave (ESW) stimulation will decrease the resting muscle activity of paralysed forearm muscles, reducing the degree of spasticity in surface electromyography examination as well as Modified Ashworth Scale (MAS). ESW stimulation will also contribute to enhance of average and maximum temperature of examined tissues as a result of improved trophic condition at the microcirculation level in thermal imaging.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaIschemic stroke episode > 9 months previously, level of spasticity in MAS > 1, no antispastic interventions (surgical, pharmacological, rehabilitation), no ESW contraindications, agreement of participant.
- Exclusion criteriaIschemic stroke episode < 9 months previously, deifferent ethiology of stroke, level of spasticity in MAS < 1, surgical antispastic interventions (rhizotomy, neurectomy, cordectomy, myotomy), antispactic pharmacotherapy (Diazepam, Baclofen, Dantrolene, Tizanidine, Botuline), antispastic rehabilitation, present contraindications to ESW stimulation (pregnancy, cancer, local tumors, coagulation disorders, acute and recurrent inflammatory states, pacemakers and other electronic implants), resignation during research, non-agreement of participant.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 2-aug-2013
- planned closingdate2-aug-2015
- Target number of participants100
- InterventionsStudy group: radial ESW stimulation on bellies of carpal flexor radialis and carpal flexor medialis muscles within spastic paresis. ESW parameters: numer of shots (S) = 1500, pressure (P) = 1.5 bar, energy density (E) = 0.10 mJ/mm2, frequency (f) = 10 Hz, applicator diameter (d) = 15 mm. Placebo group: sham ESW without active biologically component will be applied, preserving appropriate duration, imitating the active stimulation. The special polyethylene cap energy damping filled with sponge will be used.
- Primary outcomeThe surface electromyography Noraxon MyoSystem 1400A (Noraxon, USA) will be used to obtain reliable analysis of the muscle bioelectrical activity, expressed as the resting muscle tone of affected muscles. Mean rest muscle tension, expressed in microvolts [μV], will be recorded, determined as the arithmetic mean value of muscle tension in the examined group of muscles for the entire period of measurement per time unit [s]. The infrared camera MobIR M8 (Test-Therm, Poland) will be used to register thermal phenomena at the vascular level in examined muscles, as well as to visualize changes in local temperature distribution of stimulated tissues. The mean value of the tissue heat level within examined muscles will be determined, taken as the arithmetic mean of each isotherm within the whole area of measurement, expressed in Celsius degrees [°C]. The maximal and minimal temperature of the examined area also will be established, taken as a set of points with the highest level of heat within the area of measurement, expressed in Celsius degrees [°C].
- Secondary outcomeThe Modified Ashworth Scale will be use to assess clinical changes in muslces spaticity level, before and after ESW stimulation or placebo intervention.
- TimepointsIn the first stage, all the initial measurements will be performed immediately before a single application of ESW, and directly after its completion. In the second stage, final measurements will be performed after 1 and 24 hours following stimulation.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-okt-2013 - 29-okt-2013

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