Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity… (NCT02814786) | Clinical Trial Compass
TerminatedNot Applicable
Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy
Stopped: lack of inclusion
France24 participantsStarted 2016-09-08
Plain-language summary
This research will lead to the first evaluation of intrinsic and dynamic joint and muscle mechanics of equinus in cerebral palsy. It would provide a direct cause and effect relationship between equinus and bone deformity. Mechanical insights to the pathophysiology of the targeted muscles will lead to better understanding and, thus, to a better medical and surgical management of equinus deformity. Secondary aim will provide an important insight whether key gait parameters can be exclusively relied upon for surgical treatment planning and evaluation. In a medium-term perspective, depending upon the results of this study, dynamic MRI of the ankle joint may serve as a guiding tool for fixed equinus surgery in case of cerebral palsy.
Who can participate
Age range
7 Years – 14 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.
Equinus cohort inclusion criteria:
* children between 7 and 14 years old
* with unilateral CP and GMFCS score of I or II
* with the presence of fixed equinus defined as a fixed limitation of dorsiflexion inferior to 0°
Control cohort inclusion criteria:
* age and gender matched to equinus cohort
* no history of lower limb musculo-skeletal injury in past 6 months
* no history of lower limb musculoskeletal surgery in past six months
* no contraindications to MRI
Equinus cohort exclusion criteria:
* history of lower limb musculo-skeletal surgery
* botulinum toxin injection in past 6 months
* contraindications to MRI
* Uncooperative patient who refused to sign the informed consent
* Patient unable to understand the protocol, under guardianship
* Patients not affiliated to the Social Security.
Control cohort exclusion criteria:
* Uncooperative patient who refused to sign the informed consent
* Patient unable to understand the protocol, under guardianship
* Patients not affiliated to the Social Security.
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
Talocrural joint flexion, pronation, and internal rotations
Timeframe: One year
2
Subtalar joint flexion, pronation, and internal rotations