NCT05615493|Unknown
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Sponsor study identifier
interventional
112
1 country
1
Study Start
October 15, 2022
Actual (reported)Primary Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a prospective, double blinded randomized, placebo-controlled study that will be conducted on 112 adult ischemic or hemorrhagic hemiplegic stroke patients with calf muscles spasticity so as to evaluate the effectiveness of radial extracorporeal shock wave therapy (r ESWT) as an additional treatment modality for spastic equinus deformity in those patients. Allocation of patients into two groups after eligibility testing \& randomization will be done: Group I: patients will receive rESWT once weekly for one month , Group II: patients will receive Sham rESWT once weekly for one month. Each patient will be evaluated by the same well trained physiatrist for clinical, Electrophysiological and Musculoskeletal Ultrasound (MSKUS) assessments at baseline (t0), and after 1 month (t1) and after 2 months (t2) .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2022
Actual (reported)October 30, 2022
Actual (reported)November 14, 2022
Actual (reported)March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Reduction in modified Ashworth scale (MAS) for spastic plantar flexor muscles
about 6 months
Improvement of Passive ankle dorsiflexion range of motion ( PADFM) .
about 6 months
Reduction in time required to walk 10 meters (10 MWT).
about 6 months
Reduction in H/M ratio.
about 6 months
Change in spastic calf muscles echogenicity on Heckmatt scale.
about 6 months
Will receive rESWT once weekly for one month
Will receive Sham rESWT once weekly for one month
Radial extracorporeal shock wave therapy (r ESWT) will be applied by Dornier AR2 machine (Dornier MedTech GmbH, Wessling, Germany) under ultrasound guidance, at musculotendinous junction of medial and lateral head of the gastrocnemius for spastic calf (gastrocnemius muscle and the soleus) muscles . 1.500 pulses will be applied by an R20 probe with a focusing depth of 4cm.The intensity will be 0.10 mJ to 0.3mJ/mm2 (2.5 bar), with frequency 4 Hz every week for one month .No anesthetic or analgesic drugs will be administered to patients during the therapy session
Faculty of Medicine, Tanta University
Tanta, Elgharbia Governorate, 31527, Egypt
Nada DW, El Sharkawy AM, Elbarky EM, Rageh ESM, Allam AES. Radial extracorporeal shock wave therapy as an additional treatment modality for spastic equinus deformity in chronic hemiplegic patients. A randomized controlled study. Disabil Rehabil. 2024 Sep;46(19):4486-4494. doi: 10.1080/09638288.2023.2278185. Epub 2023 Nov 5.
First Submitted
October 30, 2022
First Posted
November 14, 2022
Dornier AR2 machine (Dornier MedTech GmbH, Wessling, Germany) used under ultrasound guidance, at musculotendinous junction of medial and lateral head of the gastrocnemius for spastic calf (gastrocnemius muscle and the soleus) muscles . 1.500 pulses will be applied by an R20 probe with intensity of 0.10 mJ to 0.3mJ/mm2 (2.5 bar), \& frequency 4 Hz every week for one month without operating the machine .
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
October 15, 2022
Actual (reported)Primary Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 14, 2022
Record last verified: 2022-11
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