Measuring stiffness and spasticity in children with cerebral palsy
Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy: (DYNA_PC)
This study tests a new way to measure stiffness and tightness in children with cerebral palsy to see if it can help doctors make better treatment decisions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | Fondation Ellen Poidatz Academic / other |
| Locations | 1 site (Saint-Fargeau-Ponthierry) |
| Trial ID | NCT04596852 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a protocol for measuring passive inter-segmental stiffness and spasticity in children diagnosed with cerebral palsy. By comparing clinical gait analysis with clinical examinations, the study seeks to enhance the accuracy of assessments that influence treatment decisions. The focus is on improving the reliability of measurements that currently depend on subjective evaluations by practitioners. The study includes both children with cerebral palsy and healthy children for comparison purposes.
Who should consider this trial
Good fit: Ideal candidates include children aged 7 to 18 years with a clinical diagnosis of cerebral palsy who can cooperate and follow instructions.
Not a fit: Patients who have undergone surgery or botulinum toxin injections within the last six months or those with a diagnosis of dystonia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments and better treatment options for children with cerebral palsy.
How similar studies have performed: While there is ongoing research in this area, the specific approach of validating a protocol for measuring stiffness and spasticity in this manner is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria for PC children are : * A clinical diagnosis of CP noted in the medical record * An age between 7 and 18 years old * Levels I to III for the Global Motor Function Classification System (GMFCS) * Ability to cooperate, understand and follow simple instructions * Patient affiliated to the French social security system * Voluntary patient whose parents have given their consent to participate The inclusion criteria for healthy children are : * An age between 7 and 18 years old * Ability to cooperate, understand and follow simple instructions * Patient affiliated to the French social security system * Voluntary patient whose parents have given their consent to participate Exclusion Criteria: * Medical decision for any reason * Child or parent decision for any reason * Inability to cooperate, to understand and to follow instructions * Surgery or botulinum toxin injection within 6 months prior to the start of the study. * A diagnosis of a form of dystonia.
Where this trial is running
Saint-Fargeau-Ponthierry
- Fondation Ellen Poidatz — Saint-Fargeau-Ponthierry, France (Recruiting)
Study contacts
- Principal investigator: Eric Desailly, PhD — Fondation Ellen Poidatz
- Study coordinator: Eric Desailly, PhD
- Email: eric.desailly@fondationpoidatz.com
- Phone: +33160652765
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.