Home-based stretching program for children with spastic cerebral palsy
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 tests whether a home-based stretching program can help children with spastic cerebral palsy improve their muscle flexibility and strength over six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 4 Years to 11 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04904094 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a 6-week stretching intervention on children aged 4 to 11 years with spastic cerebral palsy. The intervention includes a 2-week casting period for the lower legs followed by a home-based stretching program targeting the plantar flexors and hamstrings. The primary goals are to assess changes in muscle and tendon lengths, range of motion, stiffness, and functional muscle strength. The study aims to correlate baseline muscle properties with improvements in ankle range of motion and stiffness.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 12 years with a confirmed diagnosis of spastic cerebral palsy and GMFCS levels I-III.
Not a fit: Patients who are non-ambulatory or have had recent botulinum toxin injections or lower limb surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve muscle function and mobility in children with spastic cerebral palsy.
How similar studies have performed: Other studies have shown promising results with similar stretching interventions in improving mobility and muscle function in children with cerebral palsy.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Britta Hanssen, dr.
- Email: britta.hanssen@kuleuven.be
- Phone: +3216341016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.