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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
NCT03847545 |
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Date of registration:
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19/12/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking Technique
MUST |
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Scientific title:
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Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking |
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Date of first enrolment:
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December 12, 2018 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03847545 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Helle H. Nielsen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Odense University Hospital, Odense, Denmark |
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Name:
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Maria Thorning, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Odense University Hospital, Odense, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Fills the criteria for fampridine treatment
- Fills the diagnostic McDonald criteria for MS
- Age between 18 and 100 years
- EDSS between 4 and 7
Exclusion Criteria:
- Diagnosed epilepsy
- MS attack or an acute decrease of functional capacity within the last 60 days
- Change in immunomodulatory treatment within the last 60 days
- Cancer within the last 5 years
- Clinically significant systemic disease
- Concurrent treatment with cimetidine, carvediol, propanolol and metformine
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Fampridine
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Primary Outcome(s)
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Gait Profile Score (GPS) - (subgroup of 30 allocated to 3D gait analysis)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Secondary Outcome(s)
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Functional test - 6 Spot Step Test (SSST)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Step width - (subgroup of 30 allocated to 3D gait analysis)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Gait Variable Scores (GVS) - (subgroup of 30 allocated to 3D gait analysis)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Functional test - 2-minute Walk Test (2MWT)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Walking speed - (subgroup of 30 allocated to 3D gait analysis)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Functional test - Timed 25 Footwalk (T25-FW)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Questionnaire - 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Danish version
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Cadence - (subgroup of 30 allocated to 3D gait analysis)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Step length - (subgroup of 30 allocated to 3D gait analysis)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Stride length - (subgroup of 30 allocated to 3D gait analysis)
[Time Frame: Baseline, 14 days (Change from baseline to 14 days follow-up)]
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Secondary ID(s)
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mariathorning
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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