Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy
NCT ID: NCT04904094
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2020-02-01
2026-02-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
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.
Casting of the lower limb and homebased stretching exercise program.
Lower leg casting in combination with removable upper leg casts for approximately 2 weeks and stretching exercises during casting and 4 weeks after casting.
Control group
This group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.
No interventions assigned to this group
Interventions
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Casting of the lower limb and homebased stretching exercise program.
Lower leg casting in combination with removable upper leg casts for approximately 2 weeks and stretching exercises during casting and 4 weeks after casting.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
4 Years
11 Years
ALL
No
Sponsors
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KU Leuven
OTHER
University Ghent
OTHER
Queen Fabiola Children's University Hospital
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Kaat Desloovere, prof. dr.
Role: STUDY_DIRECTOR
KU Leuven
Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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s59945_B
Identifier Type: -
Identifier Source: org_study_id
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