Clinical trial NCT04904094: Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spastic Cerebral Palsy
Keywords: cerebral palsy
spastic cerebral palsy
stretching intervention
muscle morphology
range of motion
stiffness
spasticity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: University Ghent
name: Queen Fabiola Children's University Hospital
First posted: 2021-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in muscle belly and tendon length of the medial gastrocnemius and semitendinosus
timeFrame: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
measure: Change of range of motion of the ankle and knee joint
timeFrame: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
measure: Change of range of motion of the ankle and knee joint
timeFrame: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Secondary outcomes:
measure: Change in muscle neural (spasticity) and non-neural (stiffness) hyper-resistance
timeFrame: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
measure: Change in functional muscle strength
timeFrame: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
measure: Change in muscle echointensity
timeFrame: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
measure: Change in muscle volume
timeFrame: Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Kaat Desloovere, prof. dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Lee 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.
citation: Palisano 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.
citation: Pin 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.
citation: Theis 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.
citation: van 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.