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NCT05615493
The Effectiveness of Radial Extracorporeal Shock Wave Therapy as Additional Treatment Modality for Spastic Equinus Deformity in Chronic Hemiplegic Patients
Conditions: Hemiplegic Patients
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 112
Sponsor: Doaa Waseem Nada
Location: Egypt
Summary
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) .
Eligibility Criteria
Inclusion Criteria:Adult ischemic or hemorrhagic hemiplegic patients who exhibited signs of unilateral spastic equinus foot for at least 6 months before the enrollment in the study will be selected to reduce the confounding effect of natural recovery.Exclusion Criteria:Patients with fixed contractures or deformities at the ankle, fractures, cognitive impairment, different types of neuropathies or myopathies, implanted pacemaker and prior /or planned treatment using antispastic medications (i.e intrathecal baclofen or Botox injection ) or chemo -denervation ( phenol or alcohol nerve blocks ) within the last 6 months preceding the study , will be excluded.
Source: ClinicalTrials.gov (NCT05615493). StuddyBuddy aggregates publicly available trial information.