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

NCT03863197 | Completed Results

• 1 other identifier: S59945
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral Palsy; Spastic Cerebral Palsy; Progressive Strength Training; Muscle morphology

Outcome Measures

Primary Outcomes (6)

• Change in Muscle Size Parameter

  Estimation of muscle volume by 3D freehand ultrasonography.

  baseline, post-intervention (12-weeks)

• Change in Muscle Length

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

  baseline, post-intervention (12-weeks)

• Change in Echogenicity Intensity

  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 the muscle, therefor higher quality and a better outcome.

  baseline, post-intervention (12-weeks)

• Change in Isometric Muscle Strength

  Evaluation of isometric muscle strength by Instrumented Weakness Assessment.

  baseline, post-intervention (12-weeks)

• Change in Functional Muscle Strength - Muscle Endurance

  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.

  baseline, post-intervention (12-weeks)

• Change in Functional Muscle Strength - Maximum Jumping Distance

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

  baseline, post-intervention (12-weeks)

Secondary Outcomes (2)

• Change in Gross Motor Function

  baseline, post-intervention (12 weeks)

• Change in Walking Capacity

  baseline, post-intervention (12 weeks)

Other Outcomes (3)

• Change in Quality of Life

  baseline, post-intervention (12 weeks)

• Change in Functionality

  baseline, post-intervention (12 weeks)

• Change in Patient Reported Physical Function

  Baseline, post-intervention (12 weeks)

Study Arms (2)

Intervention group

EXPERIMENTAL

During a 12-week period children receive 3-4 sessions of progressive strength training per week on top of the usual care. All children will be provided with an individualized training program and supporting equipment. One or 2 session per week will be performed under supervision of the physical therapist, whilst the remaining sessions will be performed at home. Progression is closely monitored by the principal investigator and training programs are adjusted if necessary.

Behavioral: Progressive strength training

Waitlist-control group

NO INTERVENTION

The waitlist-control group will continue their usual care without additional treatment for 12-weeks, followed by a 12-week period of progressive supervised home-based strength training.

Interventions

Progressive strength training BEHAVIORAL

Progressive Supervised Home-based Strength Training

Intervention group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed diagnosis of SCP
• Aged 5-12 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

You may not qualify if:

• Non-ambulatory
• Botulinum toxin A injections six months prior to enrollment
• Lower limb surgery two years prior to enrollment
• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator
• University Ghent: collaborator
• Queen Fabiola Children's University Hospital: collaborator

Study Sites (2)

Universiteit Gent

Ghent, 9000, Belgium

Location

KU Leuven

Leuven, 3000, Belgium

Location

Related Publications (4)

• Hanssen B, Peeters N, Vandekerckhove I, De Beukelaer N, Bar-On L, Molenaers G, Van Campenhout A, Degelaen M, Van den Broeck C, Calders P, Desloovere K. The Contribution of Decreased Muscle Size to Muscle Weakness in Children With Spastic Cerebral Palsy. Front Neurol. 2021 Jul 26;12:692582. doi: 10.3389/fneur.2021.692582. eCollection 2021.

  PMID: 34381414 RESULT

• Hanssen B, Peeters N, De Beukelaer N, Vannerom A, Peeters L, Molenaers G, Van Campenhout A, Deschepper E, Van den Broeck C, Desloovere K. Progressive resistance training for children with cerebral palsy: A randomized controlled trial evaluating the effects on muscle strength and morphology. Front Physiol. 2022 Oct 4;13:911162. doi: 10.3389/fphys.2022.911162. eCollection 2022.

  PMID: 36267577 RESULT

• Verreydt I, Vandekerckhove I, Stoop E, Peeters N, van Tittelboom V, Van de Walle P, Van den Hauwe M, Goemans N, De Waele L, Van Campenhout A, Hanssen B, Desloovere K. Instrumented strength assessment in typically developing children and children with a neural or neuromuscular disorder: A reliability, validity and responsiveness study. Front Physiol. 2022 Oct 19;13:855222. doi: 10.3389/fphys.2022.855222. eCollection 2022.

  PMID: 36338500 RESULT

• Vandekerckhove I, Hanssen B, Peeters N, Dewit T, De Beukelaer N, Van den Hauwe M, De Waele L, Van Campenhout A, De Groote F, Desloovere K. Anthropometric-related percentile curves for muscle size and strength of lower limb muscles of typically developing children. J Anat. 2025 Aug;247(2):348-362. doi: 10.1111/joa.14241. Epub 2025 Mar 17.

  PMID: 40098309 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Britta Hanssen
• Organization: KU Leuven

britta.hanssen@kuleuven.be

+3216341295

Study Officials

• Kaat Desloovere, Dr

  KU Leuven

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Randomized controlled trial with waitlist control group

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 5, 2019
• Study Start: August 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 8, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-05

Locations

BE (2)