Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity

Completed

• Conditions: Muscle Spasticity

• Registration Number: NCT05510726
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2022-09-01
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium