The Effectiveness of Radial Extracorporeal Shock Wave Therapy as Additional Treatment Modality fo… (NCT05615493) | Clinical Trial Compass
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The Effectiveness of Radial Extracorporeal Shock Wave Therapy as Additional Treatment Modality for Spastic Equinus Deformity in Chronic Hemiplegic Patients
Egypt112 participantsStarted 2022-10-15
Plain-language 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) .
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in modified Ashworth scale (MAS) for spastic plantar flexor muscles
Timeframe: about 6 months
2
Improvement of Passive ankle dorsiflexion range of motion ( PADFM) .
Timeframe: about 6 months
3
Reduction in time required to walk 10 meters (10 MWT).
Timeframe: about 6 months
4
Reduction in H/M ratio.
Timeframe: about 6 months
5
Change in spastic calf muscles echogenicity on Heckmatt scale.