Elbow Extension Restoration Surgery in People With Tetraplegia: Evolution of the Muscular Co-activations of the Upper Limb During the Post-operative Rehabilitation

NCT03513783 | Terminated

• 1 other identifier: RC17_0466
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with C5 or C6 tetraplegia have paralysis of the triceps brachii. Elbow extension can be surgically restored by transferring the tendon from a preserved muscle onto the tendon of the paralyzed triceps brachii. The most frequently used method transfers the posterior deltoid tendon. However, transferring the posterior deltoid can create an imbalance in the shoulder joint and this technique is not recommended when the clavicular head of the pectoralis major is weak. In such cases, a preferred method is a biceps brachii tendon transfer. The success of this intervention relies on the ability of the patient to dissociate the drive between the transferred biceps brachii and the other elbow flexor muscles. Even though tendon transfers are widely used, the subsequent reorganization of muscle coordination strategies remains largely unknown. The identification of muscle synergies and co-coactivations from electromyography (EMG) signals, defined as groups of muscles activated in synchrony, may help to provide a deeper understanding of changes in muscle coordination. The objective of this study is to investigate for the first time the reorganization of muscle coordination after surgical restoration of elbow extension through the identification of muscle synergies and the quantification of muscle co-activations. Four participants with tetraplegia will take part to this study. The experimental procedure will be conducted before their surgery and once a month during 6 months after their surgery. The procedure consists of performing consecutive elbow extension-flexion cycles with the shoulder abducted at different angles. Surface and intramuscular EMG measurements will be collected for several upper limb muscles. Muscle synergies and co-activations will be extracted from the EMG measurements.

Conditions

Tetraplegia

Keywords

Spinal Cord Injury; tendon transfer; muscle synergy; muscle co-activation; electromyography

Outcome Measures

Primary Outcomes (1)

• Evolution of muscular co-activations with time

  The primary outcome measure of interest is the evolution of the muscular co-activations after the restoration surgery. Muscular co-activations represent the simultaneous activation of two or more muscles (unit %). It will be plotted against time (unit in months).

  Before and one a month for 6 months after the surgery.

Secondary Outcomes (1)

• Evolution of the extension range of motion

  Before and one a month for 6 months after the surgery.

Interventions

measurement of human movement OTHER

The objective measurement of human movement through the use of kinematic markers and electromyography is a clinical exam commonly performed to analyze the movements of patients with motor control disorders. The different steps are the following: * A clinical exam is performed by the Physical Medicine \& Rehabilitation clinician (passive range of motion , spasticity, muscular force, etc.). * Intramuscular and surface electromyography and kinematic markers are placed on the upper limb of the participant. A maximum of two intramuscular electrodes will be inserted with guiding of an echography system. * The participant will be asked to perform several upper limb movements: specifically, he will be asked to perform consecutive cycles of elbow extension-flexions with the shoulder at different levels of abduction. Times of rest will be given to the participants. Time of the procedure is estimated to 1h, with only about 2 minutes of active effortless movements from the participants.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are min 18 years old.
• Participants have a tetraplegia level C5 or C6
• Participants are hospitalized at Saint Jacques hospital
• Participants are candidates to an elbow extension restoration surgery.
• Participants have health insurance

You may not qualify if:

• Participants are unable to understand or follow instructions.
• Participants are under guardianship
• Participants are under anti-thrombotic therapy
• Participants are pregnant

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 2, 2018
• Study Start: September 10, 2018
• Primary Completion: May 12, 2021
• Study Completion: September 10, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

FR (1)