NCT03863197

Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy

Completed NA Results posted Last updated 8 July 2025

What this trial tests

NA trial testing Progressive strength training in Cerebral Palsy, Spastic in 49 participants. Completed in 1 June 2021.

Timeline

1 August 2018

Primary endpoint
1 June 2021

1 June 2021

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	49
Start date	1 August 2018
Primary completion	1 June 2021
Estimated completion	1 June 2021
Sites	2 locations across Belgium

Drugs / interventions tested

• Progressive strength training

Conditions studied

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

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 5 to 11, any sex, with Cerebral Palsy, Spastic. 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 Muscle Size Parameter Primary · baseline, post-intervention (12-weeks)

Estimation of muscle volume by 3D freehand ultrasonography.

Muscle volume - rectus femoris

Group	Value	95% CI
Intervention Group	3.7	1.9 – 5.5
Waitlist-control Group	1.6	-0.1 – 3.4

Muscle volume - semitendinosis

Group	Value	95% CI
Intervention Group	1.4	-0.5 – 3.3
Waitlist-control Group	0.1	-1.8 – 2.0

Muscle volume - medial gastrocnemius

Group	Value	95% CI
Intervention Group	2.0	0.9 – 3.1
Waitlist-control Group	0.5	-0.5 – 1.6

Change in Muscle Length Primary · baseline, post-intervention (12-weeks)

Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction.

Muscle length - rectus femoris

Group	Value	95% CI
Intervention Group	3.9	0.0 – 7.7
Waitlist-control Group	5.5	1.8 – 9.3

Muscle length - semitendinosis

Group	Value	95% CI
Intervention Group	3.2	-1.3 – 7.7
Waitlist-control Group	3.0	-1.6 – 7.5

Muscle length - medial gastrocnemius

Group	Value	95% CI
Intervention Group	3.5	1.4 – 5.6
Waitlist-control Group	2.4	0.3 – 4.4

Change in Echogenicity Intensity Primary · baseline, post-intervention (12-weeks)

Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values ranging from 0 to 255). Echogenicity intensity was defined over the whole muscle volume. Echogenicity intensity refers to the brightness of a muscle seen on the ultrasound image, which reflects how much sound is being bounced back (or "echoed") by the tissue. Higher echo-intensity (i.e., higher values) often indicates increased fat or fibrous tissue within the muscle and is therefore seen as a worse outcome. Whereas low echo-intensity (i.e., lower values) indicate less non-muscular tissue in

Echo-intensity - rectus femoris

Group	Value	95% CI
Intervention Group	-0.3	-4.6 – 3.9
Waitlist-control Group	-0.1	-4.2 – 4.1

Echo-intensity - semitendinosus

Group	Value	95% CI
Intervention Group	3.8	-1.1 – 8.7
Waitlist-control Group	3.2	-1.9 – 8.3

Echo-intensity - medial gastrocnemius

Group	Value	95% CI
Intervention Group	0.2	-3.0 – 2.4
Waitlist-control Group	1.8	-1.4 – 4.9

Change in Isometric Muscle Strength Primary · baseline, post-intervention (12-weeks)

Evaluation of isometric muscle strength by Instrumented Weakness Assessment.

Knee extension strength

Group	Value	95% CI
Intervention Group	2.5	0.8 – 4.2
Waitlist-control Group	-0.4	-2.1 – 1.2

Knee flexion strength

Group	Value	95% CI
Intervention Group	6.0	3.3 – 8.7
Waitlist-control Group	0.8	-1.9 – 3.4

Plantar flexion strength

Group	Value	95% CI
Intervention Group	3.6	2.2 – 5.0
Waitlist-control Group	1.1	-0.3 – 2.5

Change in Functional Muscle Strength - Muscle Endurance Primary · baseline, post-intervention (12-weeks)

Evaluation of functional muscle strength by 30-sec maximum repetition tests of the Adapted Functional Strength measure. For unilateral exercises (lateral step-up and unilateral heel raise) all affected legs were assessed.

Sit-to-stand

Group	Value	95% CI
Intervention Group	2.7	1.2 – 4.1
Waitlist-control Group	0.3	-1.3 – 1.9

Lateral step-up

Group	Value	95% CI
Intervention Group	2.7	1.4 – 3.9
Waitlist-control Group	1.1	-0.2 – 2.3

Bilateral heel raise

Group	Value	95% CI
Intervention Group	4.5	1.9 – 7.1
Waitlist-control Group	3.6	1.1 – 6.0

Unilateral heel raise

Group	Value	95% CI
Intervention Group	9.1	5.7 – 12.4
Waitlist-control Group	-1.5	-4.7 – 1.7

Change in Gross Motor Function Secondary · baseline, post-intervention (12 weeks)

Evaluation of gross motor function by the Gross Motor Function Measure (GMFM) item set. The GMFM is a standardized observational tool used to assess motor function in children with cerebral palsy by evaluating specific physical tasks across five areas: lying \& rolling, sitting, crawling \& kneeling, standing, and walking/running/jumping. Each item is scored on a 4-point scale: 0 (does not initiate), 1 (initiates but completes less than 10%), 2 (partially completes, 10% to less than 100%), and 3 (fully completes). Higher scores indicate better gross motor function, with a maximum of 66.

Group	Value	95% CI
Intervention Group	0.7	-0.6 – 2.1
Waitlist-control Group	0.3	-1.1 – 1.8

Change in Functional Muscle Strength - Maximum Jumping Distance Primary · baseline, post-intervention (12-weeks)

Evaluation of standing long jump by the Adapted Functional Strength measure.

Group	Value	95% CI
Intervention Group	5.8	-0.2 – 11.8
Waitlist-control Group	2.7	-2.8 – 8.3

Change in Walking Capacity Secondary · baseline, post-intervention (12 weeks)

Evaluation of walking capacity by assessing the distance covered during the 1-minute walking test

Group	Value	95% CI
Intervention Group	5.6	0.9 – 10.4
Waitlist-control Group	3.6	-1.0 – 8.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group

Serious: 0/26 (0%)

Deaths: 0/26

Waitlist-control Group

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention Group	Waitlist-control Group
muscle cramp or pain, joint pain and general discomfort from the weighted vest	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT03863197 adverse events section.

Sponsor's own description

A randomized controlled trail will be carried out to investigate the effect of a 12-week supervised home-based progressive strength intervention in children with spastic cerebral palsy aged 5-11 years. The results of this strength intervention aiming for increased strength and muscle hypertrophy will serve as input for a clinical decision making framework based on muscle and tendon architecture.

Publications & conference data

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

1. Progressive resistance training for children with cerebral palsy: A randomized controlled trial evaluating the effects on muscle strength and morphology.
   Hanssen B, Peeters N, De Beukelaer N, Vannerom A, et al · · 2022 · cited 17× · PMID 36267577 · DOI 10.3389/fphys.2022.911162