Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity

NCT ID: NCT05510726

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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shearwave elastography

shearwave elastography on upper or lower limb

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gaëtan Stoquart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2018/18MAI/217

Identifier Type: -

Identifier Source: org_study_id

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