Muscle-tendon Interaction in the Spastic Sural Triceps During Gait

NCT ID: NCT06474117

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2026-11-15

Brief Summary

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This project aims to study the mechanical behavior of the muscle-tendon unit (MTU) of the gastrocnemius medialis (GM) and the Achilles tendon (AT) in post-stroke and spinal cord injured (SCI) patients compared to a healthy population, focusing on the variations in muscle and tendon length during the stance phase of the gait cycle. The primary objective is to assess the respective contributions of the GM and AT lengthening in the MTU during walking. Inclusion criteria include adult post-stroke and post-SCI patients with voluntary motor function and some walking capacity. Methods include ultrasound measurements and 3D gait analysis.

Detailed Description

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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.

Conditions

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Spinal Cord Injuries Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Gait analysis coupled with ultrasound

Intervention Type OTHER

Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle

Isokinetic dynamometer with simultaneous ultrasound

Intervention Type OTHER

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.

Gait analysis coupled with ultrasound

Intervention Type OTHER

Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle

Isokinetic dynamometer with simultaneous ultrasound

Intervention Type OTHER

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.

Gait analysis coupled with ultrasound

Intervention Type OTHER

Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle

Isokinetic dynamometer with simultaneous ultrasound

Intervention Type OTHER

Measure the force/length profile of the gastrocnemius medialis muscle

Interventions

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Gait analysis coupled with ultrasound

Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle

Intervention Type OTHER

Isokinetic dynamometer with simultaneous ultrasound

Measure the force/length profile of the gastrocnemius medialis muscle

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratoire Motricité, Interactions, Performance (MIP)

UNKNOWN

Sponsor Role collaborator

Société Française de Physiothérapie (SFP).

UNKNOWN

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nantes

Nantes, Loire Atlantique, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Thomas Lecharte

Role: CONTACT

02 44 76 89 89

Fabien Lebœuf

Role: CONTACT

02 40 84 61 72

Facility Contacts

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Thomas Lecharte

Role: primary

02 44 76 89 89

Fabien Lebœuf

Role: backup

02 40 84 61 72

Other Identifiers

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2024-A01157-40

Identifier Type: OTHER

Identifier Source: secondary_id

RC24_0274

Identifier Type: -

Identifier Source: org_study_id

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