Muscle SpasticityNCT05510726
Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity
An observational study of Muscle Spasticity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- shearwave elastography
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2022to 30 May 2023
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In- or outpatients of the physical rehabilitation unit of the Cliniques universitaires Saint-Luc
Who may be able to join
- age > 18 years
- hemiparesia/-plegia following neurological condition (TBI, stroke,...)
- > 3 months after injury
- muscle overactivity in lower limb
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability, Validity, and Responsiveness of Shearwave Elastography to Assess Muscle Stiffness in Neurological Population With Muscle Overacivity
Objective:
- 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
- to investigate the relationship between muscle stiffness measured by SWE and by MyotonPro
- to investigate the correlation between muscle stiffness measured by SWE and clinical outcomes
Read more
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.
- Conditions
- Muscle Spasticity
- Being tested
- shearwave elastography
- Keywords
- spasticity, sonoelastography
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shearwave elastographyDevice
shearwave elastography on upper or lower limb
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity
expressed in m/s. A smaller shearwave velocity indicates a better outcome.
Measured: 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
Measured: 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
Measured: Day 1 + 7-14 days
Secondary outcomes (1)
muscle stiffness assessment with MyotonPro
a smaller muscle stiffness indicates a better outcome
Measured: two times day 1 at 15minutes interval + 7-14 days later at same time of the day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan Stoquart, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510726
- Sponsor's protocol ID
- 2018/18MAI/217
- Status last verified
- Jun 2023
- First submitted
- 17 Aug 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability, Validity, and Responsiveness of Shearwave Elastography to Assess Muscle Stiffness in Neurological Population With Muscle Overacivity
- ClinicalTrials.gov ID
- NCT05510726
- Acronym / sponsor ID
- 2018/18MAI/217
- Conditions
- Muscle Spasticity
- Keywords
- spasticity, sonoelastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective:
- 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
- to investigate the relationship between muscle stiffness measured by SWE and by MyotonPro
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In- or outpatients of the physical rehabilitation unit of the Cliniques universitaires Saint-Luc
Key inclusion criteria (4 listed)
- age > 18 years
- hemiparesia/-plegia following neurological condition (TBI, stroke,...)
- > 3 months after injury
- muscle overactivity in lower limb
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shearwave elastographyshearwave elastography on upper or lower limb | Device | – |
Primary outcome
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.
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
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
1 secondary outcome
muscle stiffness assessment with MyotonPro
Time frame: two times day 1 at 15minutes interval + 7-14 days later at same time of the day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Muscle Spasticity
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaëtan Stoquart, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Spasticity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reliability, validity and responsiveness shearwave elastography (SWE) to assess muscle elasticity (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.