CompletedNot Applicable

Short Term Follow-up of a Botulinum Toxin Intervention in Children With Spastic Cerebral Palsy

Belgium61 participantsStarted 2020-08-03

Plain-language summary

This study investigates the effect of integrated Botulinum Neurotoxin A (BoNT) treatment on morphologic muscle and tendon properties, spasticity, joint stiffness, joint range of motion, muscle strength, gait and gross motor function. The integrated BoNT treatment combines BoNT-injections with serial casting and intensive physical therapy, as previously described by Molenaers et al. The current study will include 30 children who are clinically scheduled for BoNT treatment in the medial gastrocnemius and/or the semitendinosus muscle in the intervention group and 30 children in a control group who will receive usual care within a time span of 3 months.

Who can participate

Age range4 Years – 11 Years

SexALL

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: * Confirmed diagnosis of spastic cerebral palsy * Aged 4-11 years * GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment) * Sufficient cooperation to comprehend and complete the test procedure * Additional exclusion criterion for the intervention group specifically: Indication for BoNT injections Exclusion Criteria: * Non-ambulatory * Botulinum toxin A injections six months prior to enrollment * Lower limb surgery two years prior to enrollment * Previous selective dorsal rhizotomy * Presence of ataxia or dystonia * Cognitive problems that impede measurements * Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks) * Hospitalization after the BoNT treatment for intensive physical therapy * Intrathecal baclofen pump * For the control group: new intervention planned within 3 months * Additional exclusion criterion for the control group specifically: new intervention planned within 3 months

What they're measuring

Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus

Timeframe: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.

Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus

Timeframe: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.

Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus

Timeframe: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.

Change in Kinematic Parameters

Timeframe: Between baseline and 8-10 weeks after the BoNT injections

Change in Gait Profile Score (Degrees)

Timeframe: Between baseline and 8-10 weeks after the BoNT injections

Change in the Spatial-temporal Parameter "Cadence".

Timeframe: Between baseline and 8-10 weeks after the BoNT injections

Trial details

NCT IDNCT05126693

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-10

Results submitted2025-05-15

View on ClinicalTrials.gov More Spastic Cerebral Palsy trials

Plain-language summary

Who can participate

Age range4 Years – 11 Years

SexALL

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

Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus

Timeframe: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.

Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus

Timeframe: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.

Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus

Timeframe: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.

Change in Kinematic Parameters

Timeframe: Between baseline and 8-10 weeks after the BoNT injections

Change in Gait Profile Score (Degrees)

Timeframe: Between baseline and 8-10 weeks after the BoNT injections

Change in the Spatial-temporal Parameter "Cadence".

Timeframe: Between baseline and 8-10 weeks after the BoNT injections