NCT06474117

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

June 19, 2024

Last Update Submit

March 3, 2026

Conditions

Keywords

GaitEchographySpinal Cord InjuryStroke

Outcome Measures

Primary Outcomes (1)

  • Length of the Achilles Tendon (AT), Muscle Fibers of the Gastrocnemius Medialis (GM), and the Muscle GM During the Single Support Phase of Walking

    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 Outcomes (1)

  • Positioning of the Muscle Fibers on the Force-Length Curve During Different Phases of Walking

    1 Day

Study Arms (3)

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

Other: Gait analysis coupled with ultrasoundOther: Isokinetic dynamometer with simultaneous ultrasound

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.

Other: Gait analysis coupled with ultrasoundOther: Isokinetic dynamometer with simultaneous ultrasound

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.

Other: Gait analysis coupled with ultrasoundOther: Isokinetic dynamometer with simultaneous ultrasound

Interventions

Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle

Healthy controlsPost-Spinal Cord Injury PatientsPost-Stroke Patients

Measure the force/length profile of the gastrocnemius medialis muscle

Healthy controlsPost-Spinal Cord Injury PatientsPost-Stroke Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects, post-stroke subject, SCI subjects

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, Loire Atlantique, 44093, France

Location

MeSH Terms

Conditions

Spinal Cord InjuriesStroke

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

November 15, 2024

Primary Completion

February 17, 2026

Study Completion

February 17, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations