Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity

Muscle Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05510726
• Other study ID #: 2018/18MAI/217
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity

Intervention

Device:
• shearwave elastography
shearwave elastography on upper or lower limb

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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