Fondation Ellen Poidatz
Saint-Fargeau-Ponthierry, France
Location status: Recruiting
NCT Number: NCT04596852
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.
Interested in participating?
Request Info7 year–18 year
All sexes
Interventional
Not applicable
Saint-Fargeau-Ponthierry, France
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria for PC children are :
The inclusion criteria for healthy children are :
Exclusion criteria
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.
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.
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.
Time frame: 2 years
Electromyography activity during passive solicitations
Time frame: 2 years
Joint kinematics during passive solicitations
Contact information is provided by the study sponsor or research team.
Axel Koussou, MS
CONTACT
Eric Desailly, PhD
CONTACT
Fondation Ellen Poidatz
Other
Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy: (DYNA_PC)
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