Study Results
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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COMPLETED
NA
25 participants
INTERVENTIONAL
2016-10-24
2020-07-31
Brief Summary
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1. Determine the correlation between quantitative muscle ultrasound (QMUS), electrical impedance myography (EIM) and currently accepted measures of physical function.
2. Determine the reliability of EIM measures performed in the home through use of a hand held device.
3. Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
SINGLE
Study Groups
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QMUS
All patients will undergo serial quantitative muscle ultrasound.
Muscle ultrasound
Ultrasound images of limb muscles will be collected.
EIM
All patients will undergo serial electrical impedance myography measures.
Electrical Impedance Myography
A painless current passes through the skin and surface electrodes are used to record the impedance through muscle.
Interventions
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Muscle ultrasound
Ultrasound images of limb muscles will be collected.
Electrical Impedance Myography
A painless current passes through the skin and surface electrodes are used to record the impedance through muscle.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to provide informed consent.
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Lisa D Hobson-Webb, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00072199
Identifier Type: -
Identifier Source: org_study_id
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