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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Assessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Éric Desailly, PhD; Phone Number: +33160652765; Email: eric.desailly@fondationpoidatz.com
• Study Contact Backup: Name: Axel Koussou, MS; Phone Number: +33160658265; Email: axel.koussou@fondationpoidatz.com

Study Locations

• France
  • Saint-Fargeau-Ponthierry, France
    • Recruiting
    • Fondation Ellen Poidatz
    • Contact: Eric Desailly, PhD; Phone Number: +33 160652765

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy children	Device: Assessment 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.
Experimental: Children with cerebral palsy	Device: Assessment 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondation Ellen Poidatz
• Investigators: Principal Investigator: Eric Desailly, PhD, Fondation Ellen Poidatz

Publications and helpful links

Helpful Links

• Website of the EllenPoidatz Foundation (See Research and Innovation)

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): November 2, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Dyna_PC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No