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

Sponsor
Nantes University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03513783
Collaborator
(none)
4
1
67
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: measurement of human movement
N/A

Detailed Description

There is a need for a detailed and quantified follow-up during rehabilitation after an elbow extension restoration in people with tetraplegia. Surface or intramuscular electromyography (EMG) gives information on muscular activation, and can detect small but clinically relevant modifications in muscular activation of patients with tetraplegia. To this day, no study measured the evolution of muscular activation in the upper limb of people with tetraplegia who underwent an elbow extension restoration surgery. 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 1h 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. Kinematic markers will be placed in order to measure the upper limb range of motion and movement velocity.

Surface EMG signals will be band-pass filtered (10-450Hz), full wave rectified, and smoothed with a low-pass filter (10Hz). Onset and offset times will be defined through the calculation of an activation threshold. For each session and each muscle, EMG amplitude will be normalized to its peak value across all trials. Each elbow extension-flexion cycle will be interpolated to 100 time points: 0-50% was extension; 50-100% flexion.

For each participant and each movement, all combinations of muscle synergies will be identified using non-negative matrix factorization (NMF) from the EMG data and data will then be averaged across the cycles. Co-activations will be directly identified from the EMG data.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Elbow Extension Restoration Surgery in People With Tetraplegia: Evolution of the Muscular Co-activations of the Upper Limb During the Post-operative Rehabilitation MouvSupReaTetra
Actual Study Start Date :
Sep 10, 2018
Anticipated Primary Completion Date :
Apr 10, 2024
Anticipated Study Completion Date :
Apr 10, 2024

Outcome Measures

Primary Outcome Measures

  1. Evolution of muscular co-activations with time [Before and one a month for 6 months after the surgery.]

    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).

Secondary Outcome Measures

  1. Evolution of the extension range of motion [Before and one a month for 6 months after the surgery.]

    The secondary outcome measure of interest is the evolution of the range of motion after the restoration surgery. The range of motion (unit °) is extracted from the kinematic data obtained through the use of markers and motion capture. It will be plotted against time (unit in months).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Participants are unable to understand or follow instructions.

  • Participants are under guardianship

  • Participants are under anti-thrombotic therapy

  • Participants are pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nantes Nantes France

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT03513783
Other Study ID Numbers:
  • RC17_0466
First Posted:
May 2, 2018
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022