- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03099993
Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia (MouvsupTCIHemi)
Quantified Analysis of the Movements of the Upper Limb of Children With Hemiparesis Participating in the Stress Induced Therapy Program
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nantes, France, 46208
- CHU de Nantes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A: Healthy volunteers
|
Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
|
Other: B: Patient with heamiplegia
|
Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
|
Other: C: Patient with heamiplegia and constraint induced therapy
arm with constraint induced therapy (done before the protocol)
|
Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper limb muscle activation envelopes
Time Frame: 5 weeks
|
Muscle activation envelopes come from electromyographic signals of upper limb muscles.
|
5 weeks
|
kinematics during active movements
Time Frame: 5 weeks
|
Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).
|
5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC15_0310
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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