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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05510726
Enrollment
30
Registered
2022-08-22
Start date
2022-09-01
Completion date
2023-05-30
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Spasticity

Keywords

spasticity, sonoelastography

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.

Interventions

shearwave elastography on upper or lower limb

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticityDay 1expressed in m/s. A smaller shearwave velocity indicates a better outcome.

Secondary

MeasureTime frameDescription
muscle stiffness assessment with MyotonProtwo times day 1 at 15minutes interval + 7-14 days later at same time of the daya smaller muscle stiffness indicates a better outcome

Other

MeasureTime frameDescription
passive range of motionday 1 + 7-14 days later at same time of the dayexpressed in angles °. The greater the angle, the better the outcome
modified ashworth scaleday 1 + 7-14 days later at same time of the dayminimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a worse outcome
Tardieu scaleday 1 + 7-14 days later at same time of the dayminimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a wourse outcome
Fugl-meyer score (Lower extremity; motor function)day 1 + 7-14 days later at same time of the daymaximum score of 34. The highest the score, the better the motor function

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026