TetraplegiaMouvSupReaTetrNCT03513783
Elbow Extension Restoration Surgery in People With Tetraplegia: Evolution of the Muscular Co-activations of the Upper Limb During the Post-operative Rehabilitation
A study testing measurement of human movement in people with Tetraplegia, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetraplegia
- What is being tested?
- measurement of human movement
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2018to 10 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants are unable to understand or follow instructions.
- Participants are under guardianship
- Participants are under anti-thrombotic therapy
- Participants are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Tetraplegia
- Being tested
- measurement of human movement
- Keywords
- Spinal Cord Injury, tendon transfer, muscle synergy, muscle co-activation, electromyography
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of human movementOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before and one a month for 6 months after the surgery.
Secondary outcomes (1)
Evolution of the extension range of motion
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).
Measured: Before and one a month for 6 months after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start10 Sep 2018
- Primary completion12 May 2021
- Study completion10 Sep 2023
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513783
- Sponsor's protocol ID
- RC17_0466
- Acronym
- MouvSupReaTetr
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2018
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03513783
- Acronym / sponsor ID
- MouvSupReaTetr / RC17_0466
- Conditions
- Tetraplegia
- Keywords
- Spinal Cord Injury, tendon transfer, muscle synergy, muscle co-activation, electromyography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Participants are unable to understand or follow instructions.
- Participants are under guardianship
- Participants are under anti-thrombotic therapy
- Participants are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of human movementThe 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. | Other | – |
Primary outcome
Evolution of muscular co-activations with time
Time frame: 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).
1 secondary outcome
Evolution of the extension range of motion
Time frame: Before and one a month for 6 months after the surgery.
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of human movement in people with Tetraplegia, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of muscular co-activations with time (time frame: Before and one a month for 6 months after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.