Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06718608

Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Stroke, Acute Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male ≥ 18 years and ≤ 80 years at screening
  • Hemiparesis secondary to a first stroke or traumatic brain injury
  • < 1 month post-stroke/brain injury Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study.

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)
  • Contraindication to perform MRI Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.

Treatment and study plan

Imaging

Diagnostic Test

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

Primary outcomes

  1. Muscle elasticity

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

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

Secondary outcomes

  1. muscle volume

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    muscle volume measured by magnetic resonance imaging, expressed in mm3. A greater muscle volume indicates a better outcome

  2. muscle fat fraction

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    muscle fat fraction measured by magnetic resonance imagine, expressed in % . A smaller fat fraction indicates a better outcome

Other outcomes

  1. passive range of motion

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    expressed in angles °. The greater the angle, the better the outcome

  2. modified ashworth scale

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a worse outcome

  3. modified Tardieu scale

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a wourse outcome

  4. Fugl-meyer score (Lower extremity; motor function)

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    maximum score of 34. The highest the score, the better the motor function

  5. 10 meter walk test

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    Expressed in seconds. A reduced time indicates a better outcome

  6. Timed Up And Go

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    Expressed in seconds. A reduced time indicates a better outcome

  7. Berg balance scale

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    maximum score of 56. The highest the score, the better the balance

  8. Abiloco

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    maximum score of 13. The highest the score, the better the outcome

  9. Stroke Impact Scale

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    maximum score of 295. The highest the score, the better the outcome

  10. Functional ambulation category

    Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion

    maximum score of 5. The highest the score, the better the outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Gaetan Stoquart, MD, PhD

CONTACT

[email protected]

Marine Devis, MD

CONTACT

[email protected]

0032476618444

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: Navomuss

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.