UnknownNot Applicable

The Effect of Botulinum Toxin and ESWT Applications on Spasticity and Functionality in Cerebral Palsy Patients

Turkey (Türkiye)40 participantsStarted 2022-11-15

Plain-language summary

Cerebral Palsy (CP) is a group of movement and posture disorders associated with a non-progressive affect during brain development that can cause limitation of activity and disability. The most common movement disorders in CP are spasticity and dystonia. Currently, the treatment of muscle stiffness called spasticity includes physiotherapy, casting and device, various drugs and surgical treatment. Botulinum toxin injection into the muscle also acts by reducing muscle contraction. ESWT is a method used in various musculoskeletal diseases. It has been previously applied to pediatric patients and has been shown to be effective and painless in ankle muscle stiffness. However, there are few studies investigating the effect of ESWT on functionality.

Who can participate

Age range

3 Years – 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: * Having a diagnosis of Spastic Cerebral Palsy confirmed by a pediatric neurologist, Patients with a spasticity value of at least 2 in the evaluation with the Modified Ashworth Scale (MAS), Patients with Botulinum Toxin injection indication by their physician, Having a mental level to understand the commands of the person making the assessment, agree to participate in the study Exclusion Criteria: * Patients diagnosed with dyskinetic, ataxic, mixed type cerebral palsy, Hypersensitivity to Onabotulinumtoxin A or any of the excipients, Infection at the planned injection site or sites, Having an uncontrolled epileptic seizure, Upper/lower extremity contracture, coagulopathy, Refusing to participate in the study, The patient is not oriented and cooperative, Contraindication of anesthesia for the group requiring anesthesia

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

Modified Tardieu Scale

Timeframe: T0:Patients will be evaluated before botulinum toxin injection.

Modified Tardieu Scale

Timeframe: T1:Patients will be evaluated 1 week after botulinum toxin injection.

Modified Tardieu Scale

Timeframe: T2:Patients will be evaluated 1 month after botulinum toxin injection.

Modified Tardieu Scale

Timeframe: T3:Patients will be evaluated 3 months after botulinum toxin injection.

Modified Tardieu Scale

Timeframe: T4:Patients will be evaluated 6 months after botulinum toxin injection.

Trial details

NCT IDNCT05627921

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-15

Contact for this trial

Nurahsen Zaben, Dr

05453492877 nrhsn_dmr@hotmail.com

View on ClinicalTrials.gov More Cerebral Palsy, Spastic trials

Plain-language summary

Who can participate

Age range

3 Years – 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.

What they're measuring

Modified Tardieu Scale

Timeframe: T0:Patients will be evaluated before botulinum toxin injection.

Modified Tardieu Scale

Timeframe: T1:Patients will be evaluated 1 week after botulinum toxin injection.

Modified Tardieu Scale

Timeframe: T2:Patients will be evaluated 1 month after botulinum toxin injection.

Modified Tardieu Scale

Timeframe: T3:Patients will be evaluated 3 months after botulinum toxin injection.

Modified Tardieu Scale

Timeframe: T4:Patients will be evaluated 6 months after botulinum toxin injection.