Clinical trial NCT05510726: Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity
Official title: Reliability, Validity, and Responsiveness of Shearwave Elastography to Assess Muscle Stiffness in Neurological Population With Muscle Overacivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Spasticity
Keywords: spasticity
sonoelastography
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In- or outpatients of the physical rehabilitation unit of the Cliniques universitaires Saint-Luc

Brief summary: Objective:

1. to investigate reliability, validity and responsiveness of shearwave elastography (SWE) to assess muscle stiffness of overactive upper or lower limb muscles in different angle joint positions in patients with neurological condition
2. to investigate the relationship between muscle stiffness measured by SWE and by MyotonPro
3. to investigate the correlation between muscle stiffness measured by SWE and clinical outcomes

Methods: each patient will be assessed three times: two times at an interval of 15 minutes on the same day and one time at an interval of one week at the same time of the day. The following measurements will be made at each evaluation: SWE, MyotonPro, clinical evaluation. SWE and MytotonPro will be taken at different angle joint position.

Outcomes: muscle stiffness measured by SWE and MyotonPro at different angle joint positions, and clinical evaluation (passive range of motion, modified ashworth scale, tardieu scale, fuglmeyer) Hypothesis: SWE is a valid, reliable, and resposive method to assess muscle stiffness in neurological population with muscle overactivity. The results of SWE will be correlated with the results of MyotonPro and with clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* hemiparesia/-plegia following neurological condition (TBI, stroke,...)
* \> 3 months after injury
* muscle overactivity in lower limb

Exclusion Criteria:

* other neurological or orthopaedic conditions involving the affected limb
* aphasia or major cognitive impairment limiting functional assessment
* botulinum toxin injection in the last 3 months
* previous treatment of muscle overactivity with surgical procedures.

Primary outcomes:
measure: reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity
timeFrame: Day 1
measure: reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity
timeFrame: Day 1 + 15 minutes
measure: reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity
timeFrame: Day 1 + 7-14 days
Secondary outcomes:
measure: muscle stiffness assessment with MyotonPro
timeFrame: two times day 1 at 15minutes interval + 7-14 days later at same time of the day
Other outcomes:
measure: passive range of motion
timeFrame: day 1 + 7-14 days later at same time of the day
measure: modified ashworth scale
timeFrame: day 1 + 7-14 days later at same time of the day
measure: Tardieu scale
timeFrame: day 1 + 7-14 days later at same time of the day
measure: Fugl-meyer score (Lower extremity; motor function)
timeFrame: day 1 + 7-14 days later at same time of the day
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Gaëtan Stoquart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: