Actively Recruiting

Phase Not Applicable
Age: 7Years - 18Years
All Genders
Healthy Volunteers
NCT04596852

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

Led by Fondation Ellen Poidatz · Updated on 2025-08-24

85

Participants Needed

1

Research Sites

269 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of cerebral palsy noted in the medical record (for CP children)
  • Age between 7 and 18 years old
  • Levels I to III on the Global Motor Function Classification System (GMFCS) (for CP children)
  • Ability to cooperate, understand, and follow simple instructions
  • Affiliated to the French social security system
  • Voluntary participation with parental consent
Not Eligible

You will not qualify if you...

  • Medical decision excluding participation for any reason
  • Child or parent decision to not participate
  • Inability to cooperate, understand, or follow instructions
  • Surgery or botulinum toxin injection within 6 months before study start
  • Diagnosis of any form of dystonia

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fondation Ellen Poidatz

Saint-Fargeau-Ponthierry, France

Actively Recruiting

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Research Team

E

Eric Desailly, PhD

CONTACT

A

Axel Koussou, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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