Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch
Sponsored by
About this trial
This is an interventional screening trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- Fondation Ellen PoidatzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy children
Children with cerebral palsy
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Electromyography Activity
Electromyography activity during passive solicitations
Joint Kinematics
Joint kinematics during passive solicitations
Full Information
NCT ID
NCT04596852
First Posted
October 15, 2020
Last Updated
September 11, 2023
Sponsor
Fondation Ellen Poidatz
1. Study Identification
Unique Protocol Identification Number
NCT04596852
Brief Title
Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy
Official Title
Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy: (DYNA_PC)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
November 2, 2023 (Anticipated)
Study Completion Date
November 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ellen Poidatz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The order of participation of evaluators is random.
Allocation
Non-Randomized
Enrollment
85 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy children
Arm Type
Experimental
Arm Title
Children with cerebral palsy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Assessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Passive Stiffness Index
Description
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
Title
Model deviation
Description
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 Outcome Measure Information:
Title
Electromyography Activity
Description
Electromyography activity during passive solicitations
Time Frame
2 years
Title
Joint Kinematics
Description
Joint kinematics during passive solicitations
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Desailly, PhD
Phone
+33160652765
Email
eric.desailly@fondationpoidatz.com
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Koussou, MS
Phone
+33160658265
Email
axel.koussou@fondationpoidatz.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Desailly, PhD
Organizational Affiliation
Fondation Ellen Poidatz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Ellen Poidatz
City
Saint-Fargeau-Ponthierry
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Desailly, PhD
Phone
160652765
Ext
+33
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.fondationpoidatz.com/
Description
Website of the EllenPoidatz Foundation (See Research and Innovation)
Learn more about this trial
Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy
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