ID

37695

Description

Wii FIT Balance Board to Recording Balance Parameters in Multiple Sclerosis Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02287948

Link

https://clinicaltrials.gov/show/NCT02287948

Keywords

Versions (1)
  1. 8/18/19 8/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Balance NCT02287948

English

Eligibility Balance NCT02287948

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Balance NCT02287948
Criteria
Description

Criteria

male and female, aged > 18, < 80 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
healthy.
Description

Healthy

Data type

boolean

Alias
UMLS CUI [1]
C3898900
exclusion criteria (healthy subjects):
Description

Exclusion Criteria Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1708335
pregnancy;
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
previous diagnosis of debilitating diseases;
Description

Debilitation Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0742985
UMLS CUI [1,2]
C0012634
previous diagnosis of orthopedic, neurological, vestibular or that may affect the balance.
Description

Orthopedic Disease Affecting Balance | Nervous system disorder Affecting Balance | Vestibular Disease Affecting Balance

Data type

boolean

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0014653
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0014653
UMLS CUI [3,1]
C0042594
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0014653
inclusion criteria (multiple sclerosis subjects):
Description

Inclusion criteria Study Subject Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0026769
male and female, aged > 18, < 80 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with a diagnosis of ms according to the mcdonald criteria in course with relapse and remission, progressive, primary or secondary are included in the study;
Description

Multiple Sclerosis | Multiple sclerosis relapse | Multiple Sclerosis Remission | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0856120
UMLS CUI [3,1]
C0026769
UMLS CUI [3,2]
C0544452
UMLS CUI [4]
C0751964
UMLS CUI [5]
C0751965
absence of disease exacerbations in the 3 months prior to enrollment;
Description

Disease Exacerbation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0235874
UMLS CUI [1,2]
C0332197
mild or moderate gait disability identified with the expanded disability status scale (edss) score not higher than 5.5. this degree of severity refers to a subject with restriction ambulatory activity but which does not require constantly an unilateral support (stick, crutch, other) for walking.
Description

Gait disability Mild | Gait disability Moderate | EDSS | Difficulty walking

Data type

boolean

Alias
UMLS CUI [1,1]
C3148980
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C3148980
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0451246
UMLS CUI [4]
C0311394
exclusion criteria (multiple sclerosis subjects):
Description

Exclusion Criteria Study Subject Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0026769
cognitive impairment assessed with mini mental status examination (mmse) <24;
Description

Impaired cognition Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0451306
neurological diseases associated with ms with possible involvement of motor functions;
Description

Nervous system disorder Associated with Multiple Sclerosis | Involvement with Motor functions Possible

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0026769
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0234130
UMLS CUI [2,3]
C0332149
of internal conditions that might interfere with the ability to complete the study protocol in a secure manner;
Description

Mental condition Interferes with Completion Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C2348563
severe cognitive-behavioral (score less than 24 on the mini mental status examination);
Description

Severe cognitive impairment Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C3554639
UMLS CUI [1,2]
C0451306
pregnancy;
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Balance NCT02287948

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Balance NCT02287948
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
male and female, aged > 18, < 80 years;
boolean
C0001779 (UMLS CUI [1])
Healthy
Item
healthy.
boolean
C3898900 (UMLS CUI [1])
Exclusion Criteria Healthy Volunteers
Item
exclusion criteria (healthy subjects):
boolean
C0680251 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Debilitation Disease
Item
previous diagnosis of debilitating diseases;
boolean
C0742985 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Orthopedic Disease Affecting Balance | Nervous system disorder Affecting Balance | Vestibular Disease Affecting Balance
Item
previous diagnosis of orthopedic, neurological, vestibular or that may affect the balance.
boolean
C0026857 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0014653 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0014653 (UMLS CUI [2,3])
C0042594 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0014653 (UMLS CUI [3,3])
Inclusion criteria Study Subject Multiple Sclerosis
Item
inclusion criteria (multiple sclerosis subjects):
boolean
C1512693 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
Age
Item
male and female, aged > 18, < 80 years;
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis | Multiple sclerosis relapse | Multiple Sclerosis Remission | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive
Item
subjects with a diagnosis of ms according to the mcdonald criteria in course with relapse and remission, progressive, primary or secondary are included in the study;
boolean
C0026769 (UMLS CUI [1])
C0856120 (UMLS CUI [2])
C0026769 (UMLS CUI [3,1])
C0544452 (UMLS CUI [3,2])
C0751964 (UMLS CUI [4])
C0751965 (UMLS CUI [5])
Disease Exacerbation Absent
Item
absence of disease exacerbations in the 3 months prior to enrollment;
boolean
C0235874 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Gait disability Mild | Gait disability Moderate | EDSS | Difficulty walking
Item
mild or moderate gait disability identified with the expanded disability status scale (edss) score not higher than 5.5. this degree of severity refers to a subject with restriction ambulatory activity but which does not require constantly an unilateral support (stick, crutch, other) for walking.
boolean
C3148980 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C3148980 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0451246 (UMLS CUI [3])
C0311394 (UMLS CUI [4])
Exclusion Criteria Study Subject Multiple Sclerosis
Item
exclusion criteria (multiple sclerosis subjects):
boolean
C0680251 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
Impaired cognition Mini-mental state examination
Item
cognitive impairment assessed with mini mental status examination (mmse) <24;
boolean
C0338656 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Nervous system disorder Associated with Multiple Sclerosis | Involvement with Motor functions Possible
Item
neurological diseases associated with ms with possible involvement of motor functions;
boolean
C0027765 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0234130 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
Mental condition Interferes with Completion Study Protocol
Item
of internal conditions that might interfere with the ability to complete the study protocol in a secure manner;
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Severe cognitive impairment Mini-mental state examination
Item
severe cognitive-behavioral (score less than 24 on the mini mental status examination);
boolean
C3554639 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
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