search
Back to results

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

Primary Purpose

Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
upper limb muscle block
4cc of lidocaïne®
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemiplegia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant woman

Sites / Locations

  • Hopital Raymond Poincaré

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hemiplegic patient

Arm Description

muscle participation in upper limb spasticity

Outcomes

Primary Outcome Measures

angles of elbow as measured by means of a goniometer

Secondary Outcome Measures

Full Information

First Posted
May 7, 2015
Last Updated
January 30, 2017
Sponsor
Centre d'Investigation Clinique et Technologique 805
search

1. Study Identification

Unique Protocol Identification Number
NCT02455232
Brief Title
Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients
Acronym
FLEXELBOW
Official Title
Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hemiplegic patient
Arm Type
Experimental
Arm Description
muscle participation in upper limb spasticity
Intervention Type
Procedure
Intervention Name(s)
upper limb muscle block
Intervention Type
Drug
Intervention Name(s)
4cc of lidocaïne®
Primary Outcome Measure Information:
Title
angles of elbow as measured by means of a goniometer
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: written consent Hemiplegic patient with spasticity and deformation of elbow Exclusion Criteria: pregnant woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Genet, PhD
Organizational Affiliation
Centre d'Investigation Clinique et Technologique 805
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Learn more about this trial

Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients

We'll reach out to this number within 24 hrs