Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity

Reliability, Validity, and Responsiveness of Shearwave Elastography to Assess Muscle Stiffness in Neurological Population With Muscle Overacivity

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.

Study Overview

• Status: Completed
• Conditions: Muscle Spasticity
• Intervention / Treatment: Device: shearwave elastography

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In- or outpatients of the physical rehabilitation unit of the Cliniques universitaires Saint-Luc

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity	expressed in m/s. A smaller shearwave velocity indicates a better outcome.	Day 1
reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity	expressed in m/s. A smaller shearwave velocity indicates a better outcome	Day 1 + 15 minutes
reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity	expressed in m/s. A smaller shearwave velocity indicates a better outcome	Day 1 + 7-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle stiffness assessment with MyotonPro	a smaller muscle stiffness indicates a better outcome	two times day 1 at 15minutes interval + 7-14 days later at same time of the day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
passive range of motion	expressed in angles °. The greater the angle, the better the outcome	day 1 + 7-14 days later at same time of the day
modified ashworth scale	minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a worse outcome	day 1 + 7-14 days later at same time of the day
Tardieu scale	minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a wourse outcome	day 1 + 7-14 days later at same time of the day
Fugl-meyer score (Lower extremity; motor function)	maximum score of 34. The highest the score, the better the motor function	day 1 + 7-14 days later at same time of the day

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Gaetan Stoquart, MD, PhD, Cliniques universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: spasticity; sonoelastography
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: 2018/18MAI/217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No