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

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ClinicalTrials.gov Identifier: NCT02455232
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Study Description
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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® Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : January 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: hemiplegic patient
muscle participation in upper limb spasticity
 Procedure: upper limb muscle block
Drug: 4cc of lidocaïne®


Outcome Measures
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Primary Outcome Measures :
  1. angles of elbow as measured by means of a goniometer [ Time Frame: 60 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant woman
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455232


Locations
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France
Hopital Raymond Poincaré
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Principal Investigator: François Genet, PhD Centre d'Investigation Clinique et Technologique 805
More Information
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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    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action