CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
Botulinum Toxin treatment combined with a post-BoNT intensive physical therapy period guided by individualized treatment goals.other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05126693
NCT05126693N/ACompleted

Algorithms for Patient-specific Treatment Planning in Cerebral Palsy Based on the Muscle and Tendon Architecture - Short Term Follow-up of a Botulinum Toxin Intervention in Children With Spastic Cerebral Palsy

Universitaire Ziekenhuizen KU Leuven·interventional·Posted Nov 19, 2021·Updated Jul 31, 2025

In Brief

A clinical study evaluating Botulinum Toxin treatment combined with a post-BoNT intensive physical therapy period guided by individualized treatment goals. for Spastic Cerebral Palsy. Completed, enrolled 61 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
CollaboratorsKU Leuven

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 19, 2021
Enrollment StartAug 3, 2020
Primary CompletionMay 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.6 years ago

Interventions

Botulinum Toxin treatment combined with a post-BoNT intensive physical therapy period guided by individualized treatment goals.other

BoNT treatment combined with a follow-up period of intensive physical therapy of 8-10 weeks. During this intensive physical therapy post BoNT injections, the children in the intervention group will work on individualized treatment goals, which will be defined based on the baseline measurements during a multidisciplinary discussion with the treating physician (planned prior to the BoNT injections).