Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy (NCT04904094) | Clinical Trial Compass
CompletedNot Applicable
Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy
Belgium30 participantsStarted 2020-02-01
Plain-language 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.
Who can participate
Age range
4 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
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.
3
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.