Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion

NCT ID: NCT06718608

Last Updated: 2024-12-05

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke, Acute Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Only one arm

Group Type EXPERIMENTAL

imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gaetan Stoquart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Marine Devis, MD

Role: CONTACT

Phone: 0032476618444

Email: [email protected]

Gaetan Stoquart, MD, PhD

Role: CONTACT

Email: [email protected]

Other Identifiers

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2024/31JUL/372

Identifier Type: -

Identifier Source: org_study_id