Spastic Cerebral PalsyNCT04904094
Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy
A study testing Casting of the lower limb and homebased stretching exercise program. in people with Spastic Cerebral Palsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study will investigate the effect of a 6-week stretching intervention, consisting of a combination of a 2-week casting period and a home-based stretching program of the plantar flexors and hamstrings, on muscle and tendon lengths, range of motion, stiffness, and functional muscle strength. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Casting of the lower limb and homebased stretching exercise program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2020to 1 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of spastic cerebral palsy
- Aged 4-12 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
- Indication for casting of the lower limb
Who cannot join
- Non-ambulatory
- Botulinum toxin A injections six months prior to enrollment
- Lower limb surgery two years prior to enrollment
- Selective dorsal rhizotomy as treatment history
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Algorithms for Patient-specific Treatment Planning in Cerebral Palsy Based on the Muscle and Tendon Architecture - Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy
This study will investigate the effect of a 6-week stretching intervention, consisting of a combination of a 2-week casting period and a home-based stretching program of the plantar flexors and hamstrings, on muscle and tendon lengths, range of motion, stiffness, and functional muscle strength. The study will include patients with spastic cerebral palsy aged between 4 and 11 years old with a Gross Motor Function Classification Score (GMFCS) level between I and III.
Read the detailed description
This study will investigate the effect of a 6-week stretching intervention on muscle and tendon lengths, range of motion, stiffness, and functional muscle strength. The program consists of a 2-week casting period of the lower legs and a home-based stretching program of the hamstrings, followed by a 4-week stretching program of both the plantar flexors and hamstrings.
The aim is twofold: (1) determine whether a 6-week stretching program for the plantar flexors and knee flexors leads to changes in the morphological muscle and tendon properties of the medial gastrocnemius and semitendinosus, ankle and knee range of motion, muscle strength, gait and gross motor function; and (2) determine the correlation between baseline morphological muscle and tendon properties and the changes in the primary outcome parameters (ankle range of motion and stiffness).
The program will start with a 2-week period of stretching casts for the ankle plantar flexors, combined with a passive stretch program for the hamstrings, followed by a passive and active stretch program for both muscle groups for the remaining 4 weeks. The durations and frequencies for passive and active stretching are based on guidelines published by our own research group and on programs applied by previous research. The program will be set-up as a supervised home-based program on top of the usual care. The morphological muscle and tendon parameters, strength, spasticity, stiffness as well as gross motor function will be assessed before and after the entire 6-week stretching program. At the time of cast removal (after 2 weeks), only the morphological muscle and tendon parameters will be evaluated.
This study includes an intervention and control group which will be group-matched based on diagnosis, GMFCS level and age. The study will include patients with spastic cerebral palsy between 4 and 11 years old and a GMFCS level between I and III. Thirty children with a clinical indication for casting of the lower limb will be included in the intervention group and 30 children without an indication for a specific intervention will be included in the control group. Children in the control group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Casting of the lower limb and homebased stretching exercise program.
- Keywords
- cerebral palsy, spastic cerebral palsy, stretching intervention, muscle morphology, range of motion, stiffness, spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casting of the lower limb and homebased stretching exercise program.Other
Lower leg casting in combination with removable upper leg casts for approximately 2 weeks and stretching exercises during casting and 4 weeks after casting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group will receive casting of the lower limb for approximately 2 weeks combined with a passive stretching program of the knee flexors, followed by a homebased stretching exercise program for the plantar flexors and hamstrings for 4 weeks after casting. Receives: Other: Casting of the lower limb and homebased stretching exercise program. |
| Control group | No intervention | This group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle belly and tendon length of the medial gastrocnemius and semitendinosus
Estimation of the muscle belly and tendon length by 3D freehand ultrasonography. The primary outcome will be the muscle belly/tendon length ratio.
Measured: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Change of range of motion of the ankle and knee joint
Evaluation by an instrumented spasticity assessment
Measured: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Change of range of motion of the ankle and knee joint
Evaluation by goniometry
Measured: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Secondary outcomes (4)
Change in muscle neural (spasticity) and non-neural (stiffness) hyper-resistance
Evaluation of muscle spasticity and stiffness by an instrumented spasticity assessment
Measured: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Change in functional muscle strength
Evaluation of functional muscle strength by the Adapted Functional Strength measure
Measured: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Change in muscle echointensity
Estimation of the echointensity by 3D freehand ultrasonography
Measured: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Change in muscle volume
Estimation of muscle volume by 3D freehand ultrasonography
Measured: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Feb 2020
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will include patients who receive casting at the lower limb for the intervention group. Patient with no indication for treatment will be asked for participation in the control group. The children in the control group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University Ghent, Queen Fabiola Children's University Hospital
- Responsible party
- Sponsor
- Investigators
- Kaat Desloovere, prof. dr., Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904094
- Sponsor's protocol ID
- s59945_B
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2020
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Franki I, Desloovere K, De Cat J, Feys H, Molenaers G, Calders P, Vanderstraeten G, Himpens E, Van Broeck C. The evidence-base for basic physical therapy techniques targeting lower limb function in children with cerebral palsy: a systematic review using the International Classification of Functioning, Disability and Health as a conceptual framework. J Rehabil Med. 2012 May;44(5):385-95. doi: 10.2340/16501977-0983.
PubMed 22549646Lee GP, Ng GY. Effects of stretching and heat treatment on hamstring extensibility in children with severe mental retardation and hypertonia. Clin Rehabil. 2008 Sep;22(9):771-9. doi: 10.1177/0269215508090067.
PubMed 18728130Palisano RJ, Rosenbaum P, Bartlett D, Livingston MH. Content validity of the expanded and revised Gross Motor Function Classification System. Dev Med Child Neurol. 2008 Oct;50(10):744-50. doi: 10.1111/j.1469-8749.2008.03089.x.
PubMed 18834387Pin T, Dyke P, Chan M. The effectiveness of passive stretching in children with cerebral palsy. Dev Med Child Neurol. 2006 Oct;48(10):855-62. doi: 10.1017/S0012162206001836.
PubMed 16978468Theis N, Korff T, Kairon H, Mohagheghi AA. Does acute passive stretching increase muscle length in children with cerebral palsy? Clin Biomech (Bristol). 2013 Nov-Dec;28(9-10):1061-7. doi: 10.1016/j.clinbiomech.2013.10.001. Epub 2013 Oct 10.
PubMed 24210836van den Noort JC, Bar-On L, Aertbelien E, Bonikowski M, Braendvik SM, Brostrom EW, Buizer AI, Burridge JH, van Campenhout A, Dan B, Fleuren JF, Grunt S, Heinen F, Horemans HL, Jansen C, Kranzl A, Krautwurst BK, van der Krogt M, Lerma Lara S, Lidbeck CM, Lin JP, Martinez I, Meskers C, Metaxiotis D, Molenaers G, Patikas DA, Remy-Neris O, Roeleveld K, Shortland AP, Sikkens J, Sloot L, Vermeulen RJ, Wimmer C, Schroder AS, Schless S, Becher JG, Desloovere K, Harlaar J. European consensus on the concepts and measurement of the pathophysiological neuromuscular responses to passive muscle stretch. Eur J Neurol. 2017 Jul;24(7):981-e38. doi: 10.1111/ene.13322. Epub 2017 May 29.
PubMed 28557247