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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Assessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch


Participation Criteria
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Eligibility Criteria
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The inclusion criteria for PC children are : 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 The inclusion criteria for healthy children are : 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 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy children<br> | Device: Assessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch<br>* 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.<br>|
| Experimental: Children with cerebral palsy<br> | Device: Assessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography Activity | Electromyography activity during passive solicitations | 2 years | 
| Joint Kinematics | Joint kinematics during passive solicitations | 2 years |