NCT05126693

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

Completed NA Results posted Last updated 31 July 2025

What this trial tests

NA trial testing Botulinum Toxin treatment combined with a post-BoNT intensive physical therapy period guided by individualized treatment goals. in Spastic Cerebral Palsy in 61 participants. Completed in 10 May 2022.

Timeline

3 August 2020

Primary endpoint
10 May 2022

10 May 2022

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	3 August 2020
Primary completion	10 May 2022
Estimated completion	10 May 2022
Sites	1 location across Belgium

Drugs / interventions tested

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

Conditions studied

• Spastic Cerebral Palsy — all drugs for Spastic Cerebral Palsy →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 4 to 11, any sex, with Spastic Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Estimation of the muscle belly volume by three-dimensional freehand ultrasonography normalized to the product of body weight and height

Medial Gastrocnemius

Group	Value	95% CI
Intervention Group	-0.08	-0.16 – 0.04
Control Group	0.00	-0.09 – 0.06

Semitendinosus

Group	Value	95% CI
Intervention Group	-0.09	-0.16 – 0.01
Control Group	-0.01	-0.07 – 0.04

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

Estimation of the echogenicity intensity of the whole muscle volume by three-dimensional freehand ultrasonography. Echogenicity is expressed in arbitrary units ranging from 0 to 255. Higher values indicate lighter images, which indirectly suggests the presence of more non-contractile muscle tissue.

Medial Gastrocnemius

Group	Value	95% CI
Intervention Group	2.74	-5.63 – 11.11
Control Group	-0.08	-3.77 – 9.33

Semitendinosus

Group	Value	95% CI
Intervention Group	6.58	-8.27 – 16.61
Control Group	5.20	-6.90 – 11.90

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

Estimation of the absolute muscle volume growth rate, calculated by: (muscle volume (mL)post-muscle volume pre)/(age (months)post-age (months)pre)

Medial Gastrocnemius

Group	Value	95% CI
Intervention Group	0.00	-1.34 – 0.97
Control Group	0.17	-0.23 – 0.87

Semitendinosus

Group	Value	95% CI
Intervention Group	-0.49	-1.45 – 0.58
Control Group	0.02	-0.39 – 0.48

Change in Kinematic Parameters Primary · Between baseline and 8-10 weeks after the BoNT injections

Estimation of the kinematic parameters throughout the whole gait cycle by three-dimensional gait analysis.

Ankle Range of Motion in Sagittal Plane

Group	Value	95% CI
Intervention Group	-1.74	-9.04 – 3.07

Ankle Angle in Sagittal Plane at Initial Contact

Group	Value	95% CI
Intervention Group	3.56	0.47 – 6.36

Maximal Ankle Angle in Sagittal Plane During Stance Phase

Group	Value	95% CI
Intervention Group	3.99	-0.32 – 9.99

Maximal Ankle Angle in Sagittal Plane During Swing Phase

Group	Value	95% CI
Intervention Group	5.34	1.16 – 9.70

Knee Range of Motion in Sagittal Plane

Group	Value	95% CI
Intervention Group	1.94	-3.79 – 8.84

Knee Angle in Sagittal Plane at Initial Contact

Group	Value	95% CI
Intervention Group	-1.69	-9.19 – 1.84

Minimal Knee Angle in Sagittal Plane During Stance

Group	Value	95% CI
Intervention Group	-2.44	-7.61 – 2.23

Change in Gait Profile Score (Degrees) Primary · Between baseline and 8-10 weeks after the BoNT injections

The Gait Profile Score (GPS) is a summary measure derived from three-dimensional gait analysis that quantifies the overall deviation of a patient's gait kinematics from a normative (typically developing) reference dataset. It is calculated as the root mean square difference between the patient's joint angle trajectories of the lower limb and the corresponding mean trajectories of typically developing individuals across a gait cycle. The GPS is expressed in degrees and is based on nine key kinematic variables: pelvic tilt, obliquity, rotation; hip flexion, abduction, rotation; knee flexion; ank

Group	Value	95% CI
Intervention Group	-1.76	-2.51 – -0.15

Change in the Spatial-temporal Parameter "Cadence". Primary · Between baseline and 8-10 weeks after the BoNT injections

Estimation of the cadence by three-dimensional gait analysis.

Group	Value	95% CI
Intervention Group	-0.05	-0.28 – 0.10

Change in the Spatial-temporal Parameter "Walking Velocity". Primary · Between baseline and 8-10 weeks after the BoNT injections

Estimation of the walking velocity by three-dimensional gait analysis.

Group	Value	95% CI
Intervention Group	0.01	-0.10 – 0.10

Change in the Spatial-temporal Parameter "Stride Length". Primary · Between baseline and 8-10 weeks after the BoNT injections

Estimation of the stride length by three-dimensional gait analysis.

Group	Value	95% CI
Intervention Group	0.02	-0.03 – 0.08

Change in Spasticity of the Medial Gastrocnemius and the Medial Hamstrings Primary · Between baseline and 8-10 weeks after the BoNT injections

Muscle activity of the medial gastrocnemius and the medial hamstrings as recorded by surface electromyography (millivolts) during a passive stretch at high velocity of the plantar flexors and the hamstrings.

Medial Gastrocnemius

Group	Value	95% CI
Intervention Group	-4.73	-15.74 – 1.31

Medial Hamstrings

Group	Value	95% CI
Intervention Group	-2.82	-7.64 – 0.21

Change in Normalized Muscle Tendon Unit Length of the Medial Gastrocnemius Secondary · 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.

Estimation of the muscle tendon unit length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length.

Group	Value	95% CI
Intervention Group	0.88	-0.22 – 1.59
Control Group	-0.35	-0.86 – 0.52

Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus Secondary · 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.

Estimation of the muscle belly length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length.

Medial Gastrocnemius

Group	Value	95% CI
Intervention Group	0.44	0.03 – 1.25
Control Group	-0.13	-0.92 – 0.71

Semitendinosus

Group	Value	95% CI
Intervention Group	-0.32	-0.90 – 1.47
Control Group	-0.22	-0.74 – 0.83

Change in Normalized Tendon Length of the Medial Gastrocnemius Secondary · 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.

Estimation of the tendon length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length.

Group	Value	95% CI
Intervention Group	-0.03	-0.88 – 1.17
Control Group	-0.26	-0.55 – 0.24

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Short-Term Impact of Botulinum Neurotoxin-A on Muscle Morphology and Gait in Children with Spastic Cerebral Palsy.
   Peeters N, Papageorgiou E, Hanssen B, De Beukelaer N, et al · · 2022 · cited 9× · PMID 36287944 · DOI 10.3390/toxins14100676