Background
Methods/design
Study setting
Objective
Trial design
Eligibility criteria
Inclusion
Exclusion
Interventions
Intervention group
Control group
Criteria for discontinuation
Outcomes
Primary endpoint
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Change in cross-sectional area of thigh muscle between pre and post intervention, as measured on CT images
Secondary endpoints
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Change in cross-sectional area of calf muscle between pre and post intervention, as measured on CT images
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Reduction in thigh and calf circumference, measured at the same sites as CT image measurements
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Thigh and calf circumference measured on CT images
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Changes in manual muscle testing results
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Aquilion™ CX TSX-101A/NA, Application Ver. V4.62JR019 (Toshiba Medical Systems Corp., Tokyo, Japan)
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SOMATOM Definition Flash VA44A, Somaris/7 Syngo CT 2012BWinNT 6.1, Service Pack 1, VA44A_08_P16 (Siemens Healthcare, Forchheim, Germany)
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Aquilion ONE™ TSX-301A/2A, Application Ver. V4.7JR004 (Toshiba Medical Systems Corp.)
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Discovery CT 750HD, Application Software, 11 MW44.11.V40_PS_HD64_G_GTL (General Electric Healthcare, Waukesha, WI, USA)
Sample size
Rationale
Methods
Assignment of intervention
Enrollment procedure
Allocation
Participant data collection
Statistical analysis
Missing data
Blinding
Post-trial care
Data management
Monitoring
Harms and benefits
Potential side effects
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Skin injury and rash at the site of belt attachment
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Aggravation of pain at the site of fracture
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Pain during EMS