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

Hemiplegia Clinical Trial

— FLEXELBOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455232
• Other study ID #: 2015-A00444-45
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: January 30, 2017
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• written consent

• Hemiplegic patient with spasticity and deformation of elbow

Exclusion Criteria:

• pregnant woman

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Procedure:
• upper limb muscle block

Drug:
• 4cc of lidocaïne®

Locations

Country	Name	City	State
France	Hopital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	angles of elbow as measured by means of a goniometer		60 minutes