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Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia (MouvsupTCIHemi)

Primary Purpose

Unilateral Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of maximal forces of elbow pronosupination and flexion-extension
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Unilateral Cerebral Palsy focused on measuring Unilateral cerebral palsy, kinematics, electromyography, constraint-induced therapy, muscle activation, upper limb, child

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants (excluding healthy volunteers) must have hemiparesis.
  • Children must be between 6 and 17 years of age. The protocol requires a minimum concentration difficult to obtain for children under 6 years.
  • Participants must be enrolled in a health insurance plan.

Exclusion Criteria:

  • Inability to understand or follow instructions during 1h30.
  • Physical incapacity to carry out the requested movements

Sites / Locations

  • CHU de Nantes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

A: Healthy volunteers

B: Patient with heamiplegia

C: Patient with heamiplegia and constraint induced therapy

Arm Description

arm with constraint induced therapy (done before the protocol)

Outcomes

Primary Outcome Measures

Upper limb muscle activation envelopes
Muscle activation envelopes come from electromyographic signals of upper limb muscles.
kinematics during active movements
Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).

Secondary Outcome Measures

Full Information

First Posted
March 20, 2017
Last Updated
June 7, 2019
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03099993
Brief Title
Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia
Acronym
MouvsupTCIHemi
Official Title
Quantified Analysis of the Movements of the Upper Limb of Children With Hemiparesis Participating in the Stress Induced Therapy Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
April 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain, before, during, or shortly after birth. These non-progressive lesions cause muscle impairments, responsible for activity limitations. These muscle impairments include muscle stiffness, and muscle weakness. Children with Unilateral CP (UCP) have these impairments on only one side of the body. To compensate for activity limitations with their impaired arm, these children over-use their non-impaired arm. The objective of constraint-induced therapy (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by forcing the child to only use its impaired arm several hours a day during several weeks of therapy. It is known using clinical tests that this therapy improves the overall motor function of the impaired arm. However, the underlying mechanisms are yet unknown. An understanding of these mechanisms would suggest ways to maximize the effectiveness of this therapy, which requires a significant commitment from the child and its family. The investigaors propose in this project a quantitative and objective evaluation of the effect of CIT on the movements of the impaired arm of children with UCP. The investogators focus their analysis on muscle activation, to assess which aspect of muscle impairments is modified by CIT. To this end, the investigators will use sensors identical to those already used in clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait disorders. Results from this study will provide leads to optimize CIT. Some children could for example benefit from CIT paired with treatments to reduce muscle stiffness or to strengthen muscles
Detailed Description
Quantitative and objective evaluation of upper limb movements will take place in a motion analysis laboratory and will take place as follow: A clinical exam of the participant will be performed by the physician to collect maximal passive joint amplitudes with a goniometer and anatomical measures (length, circumference) of the upper limb. The participant will be equipped with surface electromyographic electrodes to measure the activation of his superficial muscles, and with retroreflective markers placed on anatomical landmarks of his thorax, shoulder, and arm, to measure upper limb kinematics with a 3D motion capture system composed of 8 VICON cameras. Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer. The participant will be placed on a height adjustable bench, in the center of the laboratory. He will be asked to perform upper limb movements: A few movements not measured, to familiarize with the equipment; Recorded movements: a trial is composed of a few consecutive cycles of a movement such as elbow flexion-extension. A trial usually last about 10seconds. A few seconds-time of rest is imposed between each trial. The required movements are the following: elbow flexion-extension, elbow pronosupination, and "hand to mouth". Finally, the participant will be asked to lie down on an exam table and to rest relax, in order to measure the electromyographic signal of his muscles at rest. Duration of the protocol is about 1h30, with less than 30seconds of effort, and a few minutes of performing simple upper limb movements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Cerebral Palsy
Keywords
Unilateral cerebral palsy, kinematics, electromyography, constraint-induced therapy, muscle activation, upper limb, child

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Healthy volunteers
Arm Type
Other
Arm Title
B: Patient with heamiplegia
Arm Type
Other
Arm Title
C: Patient with heamiplegia and constraint induced therapy
Arm Type
Other
Arm Description
arm with constraint induced therapy (done before the protocol)
Intervention Type
Other
Intervention Name(s)
Measurement of maximal forces of elbow pronosupination and flexion-extension
Intervention Description
Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
Primary Outcome Measure Information:
Title
Upper limb muscle activation envelopes
Description
Muscle activation envelopes come from electromyographic signals of upper limb muscles.
Time Frame
5 weeks
Title
kinematics during active movements
Description
Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants (excluding healthy volunteers) must have hemiparesis. Children must be between 6 and 17 years of age. The protocol requires a minimum concentration difficult to obtain for children under 6 years. Participants must be enrolled in a health insurance plan. Exclusion Criteria: Inability to understand or follow instructions during 1h30. Physical incapacity to carry out the requested movements
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
46208
Country
France

12. IPD Sharing Statement

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Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia

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