Ankle-foot Orthoses for Night Splinting in Children With CP: Impact on Passive Stiffness in Plant… (NCT03686644) | Clinical Trial Compass
WithdrawnNot Applicable
Ankle-foot Orthoses for Night Splinting in Children With CP: Impact on Passive Stiffness in Plantarflexors Muscles
Stopped: never started
0Started 2018-10-16
Plain-language summary
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic Cerebral Palsy (CP). However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
Principal purpose of this study was to assess impact of night splint ankle foot orthoses on passive stiffness in plantarflexors muscles in children with CP.
Who can participate
Age range
8 Years – 16 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:
* Children diagnosed spastic cerebral palsy
* Children wearing night splint ankle foot orthoses all night long during 1 week minimum
* Children with a level of spasticity in the gastrocnemius muscle greater than or equal to X1, VII, on the Tardieu scale and 2 on the Ashworth scale.
* Children able to understand and respect the simple instructions of the study
* Children and parents who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study.
Exclusion Criteria:
* Children who do not tolerate ankle foot orthoses all night long.
* Children who had botulinum injection in gastrocnemius or soleus muscles during last three months.
* Children benefiting from an injection of botulinum toxin or the setting up of new equipment during the protocol.
* Children who do not tolerate ankle foot orthoses all night long.
* Children having benefited from plaster lengthening for less than three months.
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 from baseline elasticity modulus of the leg muscles at 4 weeks
Timeframe: Weeks 0, 1, 2, 3 and 4
Trial details
NCT IDNCT03686644
SponsorCentre Hospitalier Universitaire de Saint Etienne