RecruitingNot ApplicableNCT04596852

Protocol Validation of Dynamometric Measurement of Passive Inter-segmental 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)


Sponsor

Fondation Ellen Poidatz

Enrollment

85 participants

Start Date

Nov 2, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 7 YearsMax Age: 18 Years

Inclusion Criteria10

  • 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

Exclusion Criteria5

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAssessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch

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.


Locations(1)

Fondation Ellen Poidatz

Saint-Fargeau-Ponthierry, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04596852


Related Trials