Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity

NCT05510726 | Completed

• 1 other identifier: 2018/18MAI/217
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objective:

1. 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. 2.to investigate the relationship between muscle stiffness measured by SWE and by MyotonPro
3. 3.to investigate the correlation between muscle stiffness measured by SWE and clinical outcomes

Conditions

Muscle Spasticity

Keywords

spasticity; sonoelastography

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• muscle stiffness assessment with MyotonPro

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

Other Outcomes (4)

• passive range of motion

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

• modified ashworth scale

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

• Tardieu scale

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

Interventions

shearwave elastography DEVICE

shearwave elastography on upper or lower limb

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In- or outpatients of the physical rehabilitation unit of the Cliniques universitaires Saint-Luc

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Officials

• Gaëtan Stoquart, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 22, 2022
• Study Start: September 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)