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Clinical Trials/NCT04596852
NCT04596852
Recruiting
Not Applicable

Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy: (DYNA_PC)

Fondation Ellen Poidatz1 site in 1 country85 target enrollmentNovember 2, 2020
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Fondation Ellen Poidatz
Enrollment
85
Locations
1
Primary Endpoint
Passive Stiffness Index
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2, 2020
End Date
December 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Passive Stiffness Index

Time Frame: 2 years

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.

Model deviation

Time Frame: 2 years

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.

Secondary Outcomes

  • Joint Kinematics(2 years)
  • Electromyography Activity(2 years)

Study Sites (1)

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