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

Sponsor
Fondation Ellen Poidatz (Other)
Overall Status
Recruiting
CT.gov ID
NCT04596852
Collaborator
(none)
85
1
2
24
3.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Assessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
The order of participation of evaluators is random.
Primary Purpose:
Screening
Official Title:
Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy: (DYNA_PC)
Actual Study Start Date :
Nov 2, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Passive Stiffness Index [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.

  2. Model deviation [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.

Secondary Outcome Measures

  1. Electromyography Activity [2 years]

    Electromyography activity during passive solicitations

  2. Joint Kinematics [2 years]

    Joint kinematics during passive solicitations

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondation Ellen Poidatz Saint-Fargeau-Ponthierry France

Sponsors and Collaborators

  • Fondation Ellen Poidatz

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Fondation Ellen Poidatz
ClinicalTrials.gov Identifier:
NCT04596852
Other Study ID Numbers:
  • Dyna_PC
First Posted:
Oct 22, 2020
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2021