Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy

NCT04904094 | Recruiting

• 1 other identifier: s59945_B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Cerebral Palsy

Keywords

cerebral palsy; spastic cerebral palsy; stretching intervention; muscle morphology; range of motion; stiffness; spasticity

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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

  Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.

• Change in functional muscle strength

  Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.

• Change in muscle echointensity

  Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.

• Change in muscle volume

  Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (6)

• 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.

  PMID: 22549646 BACKGROUND

• 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.

  PMID: 18728130 BACKGROUND

• 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.

  PMID: 18834387 BACKGROUND

• 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.

  PMID: 16978468 BACKGROUND

• 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.

  PMID: 24210836 BACKGROUND

• 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.

  PMID: 28557247 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaat Desloovere, prof. dr.

  KU Leuven

  STUDY DIRECTOR

Central Study Contacts

Britta Hanssen, dr.

CONTACT

+3216341016; britta.hanssen@kuleuven.be

Lauraine Staut

CONTACT

+3216341016; lauraine.staut@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: May 27, 2021
• Study Start: February 1, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2024-12

Locations

BE (1)