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

• Sponsor: Centre d'Investigation Clinique et Technologique 805 (Other)
• Overall Status: Completed
• CT.gov ID: NCT02455232
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 8
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia	Procedure: upper limb muscle block; Drug: 4cc of lidocaïne®	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. angles of elbow as measured by means of a goniometer [60 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• written consent

• Hemiplegic patient with spasticity and deformation of elbow

Exclusion Criteria:

• pregnant woman

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Raymond Poincaré	Garches		France	92380

Sponsors and Collaborators

• Centre d'Investigation Clinique et Technologique 805

Investigators

• Principal Investigator: François Genet, PhD, Centre d'Investigation Clinique et Technologique 805

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre d'Investigation Clinique et Technologique 805
• ClinicalTrials.gov Identifier: NCT02455232
• Other Study ID Numbers: 2015-A00444-45
• First Posted: May 27, 2015
• Last Update Posted: Jan 31, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Hemiplegia; Lidocaine

Study Results

No Results Posted as of Jan 31, 2017