Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion

NCT06718608 | Not Yet Recruiting

• 1 other identifier: 2024/31JUL/372
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to carry out a single center, prospective, interventional trial to assess the natural evolution of lower limb muscle structure and muscle stiffness of hemiparetic patients following brain damage. Patients will be assessed two weeks, one month, three months and six months after their brain lesion. Secondary objectives: To compare the muscle stiffness and structure of patients who will develop muscle overactivity to patients who won't develop muscle overactivity. To compare the muscle structure and muscle stiffness of the spastic lower limb muscles and the non-spastic lower limb muscles in the affected limb. To compare the muscle structure and muscle stiffness of the affected and the non-affected lower limb. To study the relationship between impairment and function by applying a comprehensive and original method to assess all aspects from muscle structure and mechanics to patient's functional capacities.

Conditions

Stroke, Acute; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Muscle elasticity

  Muscle elasticity measured by shear wave elastography, expressed in m/s. A smaller shearwave velocity indicates a better outcome

  2 weeks, 1 month, 3 months, 6 months after brain lesion

Secondary Outcomes (2)

• muscle volume

  2 weeks, 1 month, 3 months, 6 months after brain lesion

• muscle fat fraction

  2 weeks, 1 month, 3 months, 6 months after brain lesion

Other Outcomes (10)

• passive range of motion

  2 weeks, 1 month, 3 months, 6 months after brain lesion

• modified ashworth scale

  2 weeks, 1 month, 3 months, 6 months after brain lesion

• modified Tardieu scale

  2 weeks, 1 month, 3 months, 6 months after brain lesion

Study Arms (1)

Only one arm

EXPERIMENTAL

Diagnostic Test: imaging

Interventions

imaging DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI) Shear wave elastography (SWE) Electronic oscillatory device (EOD)

Only one arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male ≥ 18 years and ≤ 80 years at screening
• Hemiparesis secondary to a first stroke or traumatic brain injury

You may not qualify if:

• Bilateral limb paresis
• Major cognitive impairments limiting the functional evaluation
• Neurological or orthopedic affection interfering with the paretic limbs function
• Underlying neuromuscular disease (e.g. myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gaetan Stoquart, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine Devis, MD

CONTACT

0032476618444; marine.devis@saintluc.uclouvain.be

Gaetan Stoquart, MD, PhD

CONTACT

gaetan.stoquart@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 2, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)