Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy
1 other identifier
interventional
85
1 country
1
Brief Summary
Cerebral palsy (CP) refers to a group of movement and posture disorders responsible for activity limitation due to brain damage that occurs during fetal development or during the first year of a child's life. Given the multitude of treatment options available, the choice of treatment is a key determinant that greatly influences the potential for improvement in motor function. This choice is based in particular on a diagnosis resulting from the comparison of a Clinical Gait Analysis (CGA) and a clinical examination, carried out by a practitioner, aimed at evaluating as accurately as possible the deficiencies present in children with CP. During the latter examination, passive inter-segmental stiffness and spasticity, both limiting factors in the mobility of the child with CP, are assessed. However, there are significant uncertainties in these measurements, which depend, among other things, on the examiner's feelings. The enrichment of this clinical assessment therefore requires the introduction of quantitative and objective measures. Portable dynamometers are increasingly used to measure the resistance of a joint during passive solicitations. Thus, both passive inter-segmental stiffness and spasticity can be characterized using instrumental methods. However, in the majority of studies proposed in the literature, the biomechanical computational model used is not unified with that of the CGA, thus altering the approximation of the parameters measured on the table with those estimated during gait. However, in order to evaluate the extent to which these phenomena occur during gait, it is important to follow the same biomechanical calculation procedure. Thus, our team proposes a new dynamometric measurement protocol for passive inter-segmental stiffness and spasticity adapted to the PC child. Nevertheless, in order to guarantee the reliability of the measurements, manual dynamometric solicitation methods must follow standardized protocols, and their psychometric properties must be defined before they can be used in clinical practice. This is why we wish to study the reliability of this new solution for dynamometric quantification of passive inter-segmental stiffness and spasticity in children with CP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
November 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 24, 2025
August 1, 2025
3 years
October 15, 2020
August 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Passive Stiffness Index
A stiffness index representing the evolution of the resistance to passive stretch as a function of the angular amplitude. A higher score means that the joint is stiffer.
2 years
Model deviation
The root mean square deviation between the passive moment predicted by a passive stiffness model, defined at low velocity, and the passive moment measured at high velocity. A higher score means that the subject's spasticity is more important.
2 years
Secondary Outcomes (2)
Electromyography Activity
2 years
Joint Kinematics
2 years
Study Arms (2)
Healthy children
EXPERIMENTALChildren with cerebral palsy
EXPERIMENTALInterventions
Passive solicitations of the main joints of the lower limb, of healthy children and children with cerebral palsy, are realized by two evaluators with a handheld dynamometer. Repeated measures are performed to assess intra and inter-reliability.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation Ellen Poidatz
Saint-Fargeau-Ponthierry, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Desailly, PhD
Fondation Ellen Poidatz
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- The order of participation of evaluators is random.
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2020
First Posted
October 22, 2020
Study Start
November 2, 2020
Primary Completion
November 2, 2023
Study Completion
December 31, 2025
Last Updated
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share