RecruitingNot Applicable

Effects of Botulinum Toxin Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy

Turkey (Türkiye)20 participantsStarted 2025-03

Plain-language summary

This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy

Who can participate

Age range

2 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: * Diagnosed with cerebral palsy. * Spasticity in at least one of the lower extremity muscle groups. * No contraindications to shockwave therapy. * Applied Botulinum Toxin Type A injection for at least one spastic muscle of lower extremity. * Agreed to participate to study (patient/primary caregiver) Exclusion Criteria: * Surgery history within the last year of the muscle to be injected and treated * Having uncontrolled epilepsy. * Having infection * Coagulopathy

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 Aschworth Scale

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Modified Tradiue Scale

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Modified Timed Up and Go Test

Timeframe: 3 months (before injection, first week, first month and third month after injection.

Facies Pain Scale Revised

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Passive Range of Motion

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Goal Attaintment Scale

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Trial details

NCT IDNCT06494618

SponsorIstanbul Medeniyet University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05

Contact for this trial

Ismail Hakan Akbulut, Resident

+905549151240 hakan__akbulut@hotmail.com

View on ClinicalTrials.gov More Cerebral Palsy, Spastic trials

Who can participate

Age range

2 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 Aschworth Scale

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Modified Tradiue Scale

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Modified Timed Up and Go Test

Timeframe: 3 months (before injection, first week, first month and third month after injection.

Facies Pain Scale Revised

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Passive Range of Motion

Timeframe: 3 months (before injection, first week, first month and third month after injection.)

Goal Attaintment Scale

Timeframe: 3 months (before injection, first week, first month and third month after injection.)