ID

35726

Description

Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear; ODM derived from: https://clinicaltrials.gov/show/NCT02451722

Link

https://clinicaltrials.gov/show/NCT02451722

Keywords

Versions (1)
  1. 3/18/19 3/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT02451722

English

Eligibility Diabetes Mellitus Type 2 NCT02451722

1 forms  
Criteria
Description

Criteria

signing of informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
diabetes mellitus type 2
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
no major foot deformations necessitating fitting of personalized foot wear
Description

Foot Deformity Major Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0016506
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0332197
absence of diabetic foot ulcers and existence of sensory neuropathy confirmed by a physician
Description

Diabetic foot ulcer Absent | Sensory neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C1456868
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0151313
intact cognitive function
Description

Cognitive function Intact

Data type

boolean

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0205266
normal gait
Description

Gait normal

Data type

boolean

Alias
UMLS CUI [1]
C0231683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an orthopedic or rheumatic disease that negatively influences range of motion, strength, gait or balance
Description

Musculoskeletal Disease Influence Negative Range of Motion | Rheumatism Influence Negative Range of Motion | Musculoskeletal Disease Influence Negative Strength | Rheumatism Influence Negative Strength | Musculoskeletal Disease Influence Negative Gait | Rheumatism Influence Negative Gait | Musculoskeletal Disease Influence Negative Balance | Rheumatism Influence Negative Balance

Data type

boolean

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C1513916
UMLS CUI [1,4]
C0080078
UMLS CUI [2,1]
C0035435
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C1513916
UMLS CUI [2,4]
C0080078
UMLS CUI [3,1]
C0026857
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C1513916
UMLS CUI [3,4]
C0237897
UMLS CUI [4,1]
C0035435
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C1513916
UMLS CUI [4,4]
C0237897
UMLS CUI [5,1]
C0026857
UMLS CUI [5,2]
C4054723
UMLS CUI [5,3]
C1513916
UMLS CUI [5,4]
C0016928
UMLS CUI [6,1]
C0035435
UMLS CUI [6,2]
C4054723
UMLS CUI [6,3]
C1513916
UMLS CUI [6,4]
C0016928
UMLS CUI [7,1]
C0026857
UMLS CUI [7,2]
C4054723
UMLS CUI [7,3]
C1513916
UMLS CUI [7,4]
C0014653
UMLS CUI [8,1]
C0035435
UMLS CUI [8,2]
C4054723
UMLS CUI [8,3]
C1513916
UMLS CUI [8,4]
C0014653
neurological diseases that influence proprioception , strength, balance, cognitive function / understanding, sight: cerebro-vascular accident, dementia, spinal cord injury, head injury, parkinson etc.
Description

Nervous system disorder Influence Proprioception | Nervous system disorder Influence Strength | Nervous system disorder Influence Balance | Nervous system disorder Influence Cognitive function | Nervous system disorder Influence Comprehension | Nervous system disorder Influence Vision | Cerebrovascular accident | Dementia | Spinal Cord Injuries | Craniocerebral Trauma | Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0033499
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0237897
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C0014653
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C0392335
UMLS CUI [5,1]
C0027765
UMLS CUI [5,2]
C4054723
UMLS CUI [5,3]
C0162340
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C4054723
UMLS CUI [6,3]
C0042789
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0497327
UMLS CUI [9]
C0037929
UMLS CUI [10]
C0018674
UMLS CUI [11]
C0030567
injury or disease that can influence normal gait
Description

Injury Influence Normal gait | Disease Influence Normal gait

Data type

boolean

Alias
UMLS CUI [1,1]
C3263723
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0231683
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0231683
need for assistive devices : crutches, cane, walker
Description

Use of assistive device | Crutches | Cane | Walker

Data type

boolean

Alias
UMLS CUI [1]
C4061127
UMLS CUI [2]
C0010397
UMLS CUI [3]
C0006856
UMLS CUI [4]
C0043016
dialysis treatment
Description

Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0011946
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Similar models

Eligibility Diabetes Mellitus Type 2 NCT02451722

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
Item
signing of informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus type 2
boolean
C0011860 (UMLS CUI [1])
Foot Deformity Major Absent
Item
no major foot deformations necessitating fitting of personalized foot wear
boolean
C0016506 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Diabetic foot ulcer Absent | Sensory neuropathy
Item
absence of diabetic foot ulcers and existence of sensory neuropathy confirmed by a physician
boolean
C1456868 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0151313 (UMLS CUI [2])
Cognitive function Intact
Item
intact cognitive function
boolean
C0392335 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
Gait normal
Item
normal gait
boolean
C0231683 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Musculoskeletal Disease Influence Negative Range of Motion | Rheumatism Influence Negative Range of Motion | Musculoskeletal Disease Influence Negative Strength | Rheumatism Influence Negative Strength | Musculoskeletal Disease Influence Negative Gait | Rheumatism Influence Negative Gait | Musculoskeletal Disease Influence Negative Balance | Rheumatism Influence Negative Balance
Item
an orthopedic or rheumatic disease that negatively influences range of motion, strength, gait or balance
boolean
C0026857 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0080078 (UMLS CUI [1,4])
C0035435 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0080078 (UMLS CUI [2,4])
C0026857 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
C0237897 (UMLS CUI [3,4])
C0035435 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C1513916 (UMLS CUI [4,3])
C0237897 (UMLS CUI [4,4])
C0026857 (UMLS CUI [5,1])
C4054723 (UMLS CUI [5,2])
C1513916 (UMLS CUI [5,3])
C0016928 (UMLS CUI [5,4])
C0035435 (UMLS CUI [6,1])
C4054723 (UMLS CUI [6,2])
C1513916 (UMLS CUI [6,3])
C0016928 (UMLS CUI [6,4])
C0026857 (UMLS CUI [7,1])
C4054723 (UMLS CUI [7,2])
C1513916 (UMLS CUI [7,3])
C0014653 (UMLS CUI [7,4])
C0035435 (UMLS CUI [8,1])
C4054723 (UMLS CUI [8,2])
C1513916 (UMLS CUI [8,3])
C0014653 (UMLS CUI [8,4])
Nervous system disorder Influence Proprioception | Nervous system disorder Influence Strength | Nervous system disorder Influence Balance | Nervous system disorder Influence Cognitive function | Nervous system disorder Influence Comprehension | Nervous system disorder Influence Vision | Cerebrovascular accident | Dementia | Spinal Cord Injuries | Craniocerebral Trauma | Parkinson Disease
Item
neurological diseases that influence proprioception , strength, balance, cognitive function / understanding, sight: cerebro-vascular accident, dementia, spinal cord injury, head injury, parkinson etc.
boolean
C0027765 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0033499 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0237897 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0014653 (UMLS CUI [3,3])
C0027765 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C0392335 (UMLS CUI [4,3])
C0027765 (UMLS CUI [5,1])
C4054723 (UMLS CUI [5,2])
C0162340 (UMLS CUI [5,3])
C0027765 (UMLS CUI [6,1])
C4054723 (UMLS CUI [6,2])
C0042789 (UMLS CUI [6,3])
C0038454 (UMLS CUI [7])
C0497327 (UMLS CUI [8])
C0037929 (UMLS CUI [9])
C0018674 (UMLS CUI [10])
C0030567 (UMLS CUI [11])
Injury Influence Normal gait | Disease Influence Normal gait
Item
injury or disease that can influence normal gait
boolean
C3263723 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0231683 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0231683 (UMLS CUI [2,3])
Use of assistive device | Crutches | Cane | Walker
Item
need for assistive devices : crutches, cane, walker
boolean
C4061127 (UMLS CUI [1])
C0010397 (UMLS CUI [2])
C0006856 (UMLS CUI [3])
C0043016 (UMLS CUI [4])
Dialysis
Item
dialysis treatment
boolean
C0011946 (UMLS CUI [1])
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