CompletedPhase 4

Effect of Botulinum Toxin on Selective Motor Control and Pain in Diplegic Cerebral Palsy

Turkey (Türkiye)40 participantsStarted 2022-06-25

Plain-language summary

The aim of this study is to investigate the effects of Botulinum Neurotoxin-A (BoNT-A) injection applied to spastic muscles on pain sensation and Selective Motor Control (SMC) in cases diagnosed with diplegic spastic Cerebral Palsy.

Who can participate

Age range

4 Years – 12 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: * Patients diagnosed with Cerebral Palsy * Between the ages of 4-12 * GMFCS (Gross Motor Function Classification System)1-4 * Patients who have received an appropriate indication for BoNT-A injection from an experienced physiatrist * Patients who have not had botulinum toxin administered in the last 6 months Exclusion Criteria: * Mental retardation * GMFCS 5 * Have an intrathecal baclofen pump for spasticity treatment or history of soft tissue and/or bone surgery * Underwent dorsal rhizotomy * Have an active infection or a localized skin infection at the injection site * Using aminoglycoside antibiotics * Contracture

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

SCALE (Selective Control Assessment of the Lower Extremity)

Timeframe: six weeks

Boyd and Graham SMC Test

Timeframe: six weeks

Visual Analog Scale (VAS)

Timeframe: six weeks

Trial details

NCT IDNCT06583343

SponsorGaziosmanpasa Research and Education Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-05-25

View on ClinicalTrials.gov More Cerebral Palsy Spastic Diplegia trials

Who can participate

Age range

4 Years – 12 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.