Clinical trial NCT06718608: Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion
Official title: Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Acute
Traumatic Brain Injury
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscle elasticity
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
Secondary outcomes:
measure: muscle volume
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: muscle fat fraction
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
Other outcomes:
measure: passive range of motion
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: modified ashworth scale
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: modified Tardieu scale
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: Fugl-meyer score (Lower extremity; motor function)
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: 10 meter walk test
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: Timed Up And Go
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: Berg balance scale
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: Abiloco
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: Stroke Impact Scale
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
measure: Functional ambulation category
timeFrame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Gaetan Stoquart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: