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OpenTrials
Completed

NCT Number: NCT05510726

Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity

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.

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Key information

Conditions

Muscle Spasticity Muscle Hypertonia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

shearwave elastography

Device

shearwave elastography on upper or lower limb

Primary outcomes

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

    Time frame: Day 1

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

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

    Time frame: Day 1 + 15 minutes

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

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

    Time frame: Day 1 + 7-14 days

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

Secondary outcomes

  1. muscle stiffness assessment with MyotonPro

    Time frame: 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

Other outcomes

  1. passive range of motion

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

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

  2. modified ashworth scale

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

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

  3. Tardieu scale

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2022
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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