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Table 1 Schedule of assessments

From: Clinical trial readiness to solve barriers to drug development in FSHD (ReSolve): protocol of a large, international, multi-center prospective study

Visits Visit 1 Visit 2 Visit 3 Visit 4
Day 1 Day 2
Time (Month) 0 3 12 18
+/− 1 Week +/− 2 Weeks +/−  2 Weeks
Obtain Consent X     
Confirm Eligibility X     
Urine Pregnancy Testa X   X X X
History and Physical Exam X   X X X
Blood for FSHD DNA Testing X   X   
Blood for Serum Extraction X   X X X
Blood for RNA (PAX gene tube) X   X   
Blood for Plasma (EDTA tube) X   X X X
PROs: FSHD-HI, PROMIS57, UEFI, and FDI physical score X   X   X
Electrical Impedance Myography X X X X X
FSHD-COM / MFM Domain 1 X X X X X
Strength Testing: QMT and MMT X   X X X
Bedside spirometry X   X X X
DEXA X    X  
Clinical Severity Scores X   X X X
Iowa Oral Performance Instrument X X X X X
Reachable Workspace X X X X X
Fall/Exercise Questionnaire X   X X X
Fall Assessmentb    X   
“Domain-delta” questionnaire    X X  
  1. aUrine pregnancy test for women of childbearing age, b weekly × 12 weeks after the month 3 visit
  2. Assessments occur at baseline, 3, 12, and 18 months. The FSHD-COM, electrical impedance myography, MFM Domain 1, Iowa Oral Performance Instrument, and Reachable Workspace are performed on Day 1 and Day 2 of the baseline visit in order to establish intra-rater reliability