- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06474117
Muscle-tendon Interaction in the Spastic Sural Triceps During Gait (GEcho)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective: Evaluate the respective contributions of the gastrocnemius medialis (GM) muscle and the Achilles tendon (AT) within the muscle-tendon unit (MTU) during the single support phase of walking in post-stroke patients compared to healthy subjects.
Study Description: Strokes often lead to spastic paresis, degrading patients' walking performance. Instrumented gait analysis allows for the evaluation of these performances to propose adapted therapeutic strategies. This project will compare muscle and tendon behavior during walking between healthy individuals and post-stroke patients.
Methodology:
- Participants: Adult post-stroke patients or incomplete SCI patients with voluntary motor function on the triceps surae and walking capacity. Control group composed of healthy adults.
Procedures:
- Measure the force/length profile of the GM on an isokinetic dynamometer with simultaneous ultrasound.
- Conduct gait analysis coupled with ultrasound to measure the lengths of the AT and GM.
- Compare muscle and tendon length data during the stance phase of the gait cycle between the two groups.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Loire Atlantique
-
Nantes, Loire Atlantique, France, 44093
- CHU de Nantes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria :
Post-Stroke Population:
- Adult male or female
- Patient who had a stroke more than 7 days ago
- Patient hospitalized (in conventional hospitalization or day hospital) in the university neurological rehabilitation department of CHU de Nantes
- Patient with voluntary motor function graded between 2 and 4 on the MRC (Medical Research Council) scale at the GM level
- Patient classified between 3 and 8 on the New Functional Ambulation Classification
Post-Spinal Cord Injury Population:
- Adult male or female
- Patient with an incomplete spinal cord injury classified as ASIA AIS C or D from level C2 to L5
- Patient hospitalized (in conventional hospitalization or day hospital) in the neurological rehabilitation department of CHU de Nantes
- Patient with voluntary motor function graded between 2 and 4 on the MRC (Medical Research Council) scale at the GM level
- Patient classified between 3 and 8 on the New Functional Ambulation Classification
Healthy Population:
• Adult male or female without any neurological disorders
Exclusion Criteria :
Post-Stroke and Post-Spinal Cord Injury Population:
- Minor patient
- History of calf surgery, surgery to reduce triceps surae spasticity, or intramuscular injection (e.g., botulinum toxin) in the plantar flexors within the last 6 months
- Patient with a progressive condition contraindicating physical exertion (e.g., syrinx, cardiovascular instability)
- Peripheral pathology of the considered lower limb
Healthy Population:
- History of calf surgery
- History of muscle injury, fracture, or sprain of the lower limb within the last 3 months
- History of neurological disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Post-Stroke Patients
Patients will undergo gait analysis coupled with ultrasound to measure the lengths of the Achilles tendon and gastrocnemius medialis muscle.
They will also have their force/length profile of the GM measured on an isokinetic dynamometer with simultaneous ultrasound
|
Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle
Measure the force/length profile of the gastrocnemius medialis muscle
|
|
Post-Spinal Cord Injury Patients
Similar to the post-stroke group, these patients will undergo gait analysis coupled with ultrasound to measure the lengths of the Achilles tendon and gastrocnemius medialis muscle.
The force/length profile of the GM will also be measured on an isokinetic dynamometer with simultaneous ultrasound.
|
Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle
Measure the force/length profile of the gastrocnemius medialis muscle
|
|
Healthy controls
The healthy control group will undergo the same gait analysis and ultrasound measurements as the patient groups.
Their force/length profile of the GM will also be measured on an isokinetic dynamometer with simultaneous ultrasound for comparison with the post-stroke and post-spinal cord injury groups.
|
Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle
Measure the force/length profile of the gastrocnemius medialis muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of the Achilles Tendon (AT), Muscle Fibers of the Gastrocnemius Medialis (GM), and the Muscle GM During the Single Support Phase of Walking
Time Frame: 1 Day
|
This measure involves the use of ultrasound to assess the lengths of the Achilles tendon, muscle fibers of the gastrocnemius medialis, and the entire muscle GM during the single support phase of the gait cycle in post-stroke and SCI patients compared to healthy controls.
The primary goal is to determine the contributions of the muscle and tendon to the overall muscle-tendon unit during walking.
|
1 Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positioning of the Muscle Fibers on the Force-Length Curve During Different Phases of Walking
Time Frame: 1 Day
|
This outcome measure evaluates the positioning of the muscle fibers of the gastrocnemius medialis on the force-length curve during various phases of the gait cycle, including the single support phase and the double support phases (reception and propulsion).
The measurements will be compared between post-stroke, SCI patients and healthy controls.
The assessment will involve ultrasound measurements and isokinetic dynamometry to determine the force-length relationship.
|
1 Day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Stroke
- Spinal Cord Injuries
- Physical Phenomena
- Radiation
- Radiation, Nonionizing
- Ultrasonic Waves
- Sound
- High-Energy Shock Waves
Other Study ID Numbers
- RC24_0274
- 2024-A01157-40 (Other Identifier: ANSM (IDRCB))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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