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CompletedNCT05510726Updated Jun 18, 2023

Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity

An observational study in Muscle Spasticity, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Muscle Spasticity

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Keywords

  • spasticity
  • sonoelastography
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Target follow-up
1 Week
Patient registry
Yes

Interventions

  • Deviceshearwave elastography

    shearwave elastography on upper or lower limb

06

What researchers measure

Primary outcomes

  1. reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity

    expressed in m/s. A smaller shearwave velocity indicates a better outcome.

    Time frame: Day 1

  2. reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity

    expressed in m/s. A smaller shearwave velocity indicates a better outcome

    Time frame: Day 1 + 15 minutes

  3. reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity

    expressed in m/s. A smaller shearwave velocity indicates a better outcome

    Time frame: Day 1 + 7-14 days

Secondary outcomes

  1. muscle stiffness assessment with MyotonPro

    a smaller muscle stiffness indicates a better outcome

    Time frame: two times day 1 at 15minutes interval + 7-14 days later at same time of the day

Other outcomes

  1. passive range of motion

    expressed in angles °. The greater the angle, the better the outcome

    Time frame: day 1 + 7-14 days later at same time of the day

  2. modified ashworth scale

    minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a worse outcome

    Time frame: day 1 + 7-14 days later at same time of the day

  3. Tardieu scale

    minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a wourse outcome

    Time frame: day 1 + 7-14 days later at same time of the day

  4. Fugl-meyer score (Lower extremity; motor function)

    maximum score of 34. The highest the score, the better the motor function

    Time frame: day 1 + 7-14 days later at same time of the day

07

Study locations

1 site
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05510726
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Aug 22, 2022
Start date
Sep 1, 2022
Primary completion
May 30, 2023
Completion
May 30, 2023
Last update
Jun 18, 2023

Study contacts

Gaëtan Stoquart, MD, PhD
principal investigator · Cliniques universitaires Saint-Luc

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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