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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorFondation Ellen Poidatz

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

    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.

Treatment groups

85 Participants
are divided into 2 treatment groups
Group A: Healthy childrenExperimental treatment 1 intervention
Group B: Children with cerebral palsyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
2 years

Secondary outcomes

1

Electromyography Activity

Electromyography activity during passive solicitations

Time frame
2 years
2

Joint Kinematics

Joint kinematics during passive solicitations

Time frame
2 years

Other outcomes

Sponsors and contacts

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