ID

36497

Description

Assistive Device Training in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02408718

Link

https://clinicaltrials.gov/show/NCT02408718

Keywords

Versions (1)
  1. 5/17/19 5/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02408718

English

Eligibility Multiple Sclerosis NCT02408718

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
multiple sclerosis of any type,
Description

Multiple Sclerosis Type Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
self-reported history of at least 1 fall in the previous year,
Description

Falls Quantity Past Year

Data type

boolean

Alias
UMLS CUI [1,1]
C0085639
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C4086728
able to walk at least 25 feet with or without an assistive device,
Description

Able to walk Feet Quantity | Use of Assistive Device | Assistive Device Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0347981
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0036605
UMLS CUI [3,1]
C0036605
UMLS CUI [3,2]
C0332197
clinically stable multiple sclerosis (no relapse in 30 days prior to enrollment),
Description

Multiple Sclerosis Stable | Relapse Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0332197
intermittent or constant unilateral or bilateral assistance required to walk,
Description

Requirement Walking aid Unilateral Intermittent | Requirement Walking aid Bilateral Intermittent | Requirement Walking aid Unilateral Constant | Requirement Walking aid Bilateral Constant

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0557834
UMLS CUI [1,3]
C0205092
UMLS CUI [1,4]
C0205267
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0557834
UMLS CUI [2,3]
C0238767
UMLS CUI [2,4]
C0205267
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0557834
UMLS CUI [3,3]
C0205092
UMLS CUI [3,4]
C1948059
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0557834
UMLS CUI [4,3]
C0238767
UMLS CUI [4,4]
C1948059
right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.
Description

Handedness | Medication use unchanged | Physical activity Level unchanged

Data type

boolean

Alias
UMLS CUI [1]
C0023114
UMLS CUI [2,1]
C0240320
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0026606
UMLS CUI [3,2]
C0441889
UMLS CUI [3,3]
C0442739
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious psychiatric or medical conditions that would preclude reliable participation in the study,
Description

Mental condition Serious Study Subject Participation Status Excluded | Medical condition Serious Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0332196
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C0332196
dementia (mmse <24),
Description

Dementia Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
deafness,
Description

Deafness

Data type

boolean

Alias
UMLS CUI [1]
C0011053
blindness,
Description

Blindness

Data type

boolean

Alias
UMLS CUI [1]
C0456909
inability to follow directions in english,
Description

Adherence Instructions English Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C2051542
UMLS CUI [1,3]
C0376245
UMLS CUI [1,4]
C1299582
significant upper extremity tremor or weakness,
Description

EXTREMITY TREMOR, UPPER | Upper Extremity Paresis

Data type

boolean

Alias
UMLS CUI [1]
C0239412
UMLS CUI [2]
C0751409
more than 1 hour of assistive device training within the previous 3 years,
Description

Training Assistive Device Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0220931
UMLS CUI [1,2]
C0036605
UMLS CUI [1,3]
C0449238
any exclusions to receiving mri scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).
Description

MRI scan Exclusion | Implants | Anxiety | Claustrophobia | Excessive body weight gain

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C2828389
UMLS CUI [2]
C0021102
UMLS CUI [3]
C0003467
UMLS CUI [4]
C0008909
UMLS CUI [5]
C0000765
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Similar models

Eligibility Multiple Sclerosis NCT02408718

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis Type Any
Item
multiple sclerosis of any type,
boolean
C0026769 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Falls Quantity Past Year
Item
self-reported history of at least 1 fall in the previous year,
boolean
C0085639 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4086728 (UMLS CUI [1,3])
Able to walk Feet Quantity | Use of Assistive Device | Assistive Device Absent
Item
able to walk at least 25 feet with or without an assistive device,
boolean
C2712089 (UMLS CUI [1,1])
C0347981 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0036605 (UMLS CUI [2,2])
C0036605 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Multiple Sclerosis Stable | Relapse Absent
Item
clinically stable multiple sclerosis (no relapse in 30 days prior to enrollment),
boolean
C0026769 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Requirement Walking aid Unilateral Intermittent | Requirement Walking aid Bilateral Intermittent | Requirement Walking aid Unilateral Constant | Requirement Walking aid Bilateral Constant
Item
intermittent or constant unilateral or bilateral assistance required to walk,
boolean
C1514873 (UMLS CUI [1,1])
C0557834 (UMLS CUI [1,2])
C0205092 (UMLS CUI [1,3])
C0205267 (UMLS CUI [1,4])
C1514873 (UMLS CUI [2,1])
C0557834 (UMLS CUI [2,2])
C0238767 (UMLS CUI [2,3])
C0205267 (UMLS CUI [2,4])
C1514873 (UMLS CUI [3,1])
C0557834 (UMLS CUI [3,2])
C0205092 (UMLS CUI [3,3])
C1948059 (UMLS CUI [3,4])
C1514873 (UMLS CUI [4,1])
C0557834 (UMLS CUI [4,2])
C0238767 (UMLS CUI [4,3])
C1948059 (UMLS CUI [4,4])
Handedness | Medication use unchanged | Physical activity Level unchanged
Item
right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.
boolean
C0023114 (UMLS CUI [1])
C0240320 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0026606 (UMLS CUI [3,1])
C0441889 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Mental condition Serious Study Subject Participation Status Excluded | Medical condition Serious Study Subject Participation Status Excluded
Item
serious psychiatric or medical conditions that would preclude reliable participation in the study,
boolean
C3840291 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0332196 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
Dementia Mini-mental state examination
Item
dementia (mmse <24),
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Deafness
Item
deafness,
boolean
C0011053 (UMLS CUI [1])
Blindness
Item
blindness,
boolean
C0456909 (UMLS CUI [1])
Adherence Instructions English Unable
Item
inability to follow directions in english,
boolean
C1510802 (UMLS CUI [1,1])
C2051542 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
EXTREMITY TREMOR, UPPER | Upper Extremity Paresis
Item
significant upper extremity tremor or weakness,
boolean
C0239412 (UMLS CUI [1])
C0751409 (UMLS CUI [2])
Training Assistive Device Duration
Item
more than 1 hour of assistive device training within the previous 3 years,
boolean
C0220931 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
MRI scan Exclusion | Implants | Anxiety | Claustrophobia | Excessive body weight gain
Item
any exclusions to receiving mri scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).
boolean
C0024485 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2])
C0003467 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
C0000765 (UMLS CUI [5])
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