Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients (FLEXELBOW)

January 30, 2017 updated by: Centre d'Investigation Clinique et Technologique 805
The aim of this study is to determinate what are the main muscles regularly involved in the spastic pattern in flexion of the elbow using the selective motor nerve blocks of the elbow flexors. Three selective motor block nerves will be carry out in order to assess the gain of the range of motion (passive and active) of the elbow after each Motor Block Nerve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess the impact of selective motor block nerves (successively brachialis motor branch, radialis motor nerve and musculocutaneous motor branch) on passive and active ranges of motion of the elbow in stroke patients with spastic flexion pattern.

Procedure: Following the morphological landmarks already described, the brachialis motor nerve of 30 patients was blocked with 4cc of lidocaïne® 1% (electro stimulation 0.8 to 1mA) (ref). Twenty minutes after the injection, the measurement of the degree of the spasticity, the passive angle in extension and the active range of motion in flexion of the elbow were performed. Then the radialis motor nerve block was performed (at the union of the median third and lower third of the arm, medial view, 3 finger widths above the medial epicondyle) using the same procedure, in order to block the brachioradialis and the brachialis in case of double innervation. Twenty minutes after the injection, the measurement of the passive and active ranges of motion of the elbow was performed. At the end the musculocutaneous motor block nerve was performed (proximal quarter of the arm, medial view, at the base of the inferior limit of the pectoralis major and along the biceps brachii tendon) in order to make the final difference with muscle contracture if it existed a doubt.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hopital Raymond Poincare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written consent
  • Hemiplegic patient with spasticity and deformation of elbow

Exclusion Criteria:

  • pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hemiplegic patient
muscle participation in upper limb spasticity
Procedure: upper limb muscle block
Drug: 4cc of lidocaïne®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
angles of elbow as measured by means of a goniometer
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 7, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00444-45

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.

Clinical Trials on Hemiplegia

Clinical Trials on upper limb muscle block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe