ID

15590

Beskrivning

VR-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02427997

Länk

https://clinicaltrials.gov/show/NCT02427997

Nyckelord

Versioner (1)
  1. 2016-06-04 2016-06-04 -
Uppladdad den

4 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02427997

Engelsk

Eligibility Multiple Sclerosis NCT02427997

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
they are between 18-60 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
they have a confirmed diagnosis of ms (any type, e.g., rr, or sp, pp ).
Beskrivning

Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0751967
UMLS CUI [3]
C0751965
UMLS CUI [4]
C0751964
they have a score of 2 or higher on the expanded disability status scale (edss)
Beskrivning

Kurtzke multiple sclerosis rating scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
they are free from dementia as determined using the montreal cognitive assessment battery (>21) and dsm iv criteria.
Beskrivning

Dementia Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0332197
they can walk on the treadmill without partial body weight support harness for 5 minutes at their preferred walking speed; this is set as the smallest bout length at the start of training.
Beskrivning

Able to walk Treadmill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0184069
they have no history of epileptic seizures.
Beskrivning

Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
they have no ms exacerbation within the preceding 4 weeks, as determined by interview and medical notes review.
Beskrivning

Exacerbation of multiple sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0581392
they have stable ms disease treatments (e.g., last intake of steroids occurred at least 50 days before the enrolment, ms-specific drugs stable from at least 3 months, symptomatic drugs stable from at least 1 month before the enrolment).
Beskrivning

Multiple Sclerosis Therapeutic procedure Stable status | Steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0038317
they have adequate hearing (as evaluated by the whisper test and adequate vision capabilities (as measured using a snellen chart, 6.20 cut-off).
Beskrivning

Hearing normal | Hearing Test | Emmetropia | Snellen chart assessment

Datatyp

boolean

Alias
UMLS CUI [1]
C0234725
UMLS CUI [2]
C0018786
UMLS CUI [3]
C0234622
UMLS CUI [4]
C0431046
they are willing to commit to treadmill training program week and participate in all of the assessments.
Beskrivning

treadmill conditioning training Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2107089
UMLS CUI [1,2]
C0600109
they provide informed written consent and are willing to be randomized to any of the 2 study arms.
Beskrivning

Informed consent | Randomization Willing

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0600109
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
they cannot follow safety or training instructions.
Beskrivning

Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
they have another neurological disorder, unstable cardiovascular disease, diabetes, lower limb arthritis, acute lower back or lower extremity pain, peripheral neuropathy, rheumatic or severe orthopaedic problems that may interfere with walking, or have diagnosed psychiatric problems.
Beskrivning

nervous system disorder | Cardiovascular Diseases Unstable status | Diabetes Mellitus | Arthritis, unspecified, lower leg | Low Back Pain | Pain of lower extremities | Peripheral Neuropathy | Rheumatic disorder | Severe orthopedic problem Interferes with Walking | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0837966
UMLS CUI [5]
C0024031
UMLS CUI [6]
C0239376
UMLS CUI [7]
C0031117
UMLS CUI [8]
C3495832
UMLS CUI [9,1]
C0029354
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C0080331
UMLS CUI [10]
C0004936
they are pregnant.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
they are undergoing any experimental drug or other kind of therapy.
Beskrivning

Therapeutic procedure Investigational New Drugs | Therapeutic procedure Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205394
their medication regime is likely to change during the course of the study.
Beskrivning

Change of medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0580105
they are already participating in an intensive exercise program. the use of walking aids will not exclude participation.
Beskrivning

Uses effective exercise program | Walking aid

Datatyp

boolean

Alias
UMLS CUI [1]
C1820660
UMLS CUI [2]
C0557834
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Similar models

Eligibility Multiple Sclerosis NCT02427997

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
they are between 18-60 years of age.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive
Item
they have a confirmed diagnosis of ms (any type, e.g., rr, or sp, pp ).
boolean
C0026769 (UMLS CUI [1])
C0751967 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
C0751964 (UMLS CUI [4])
Kurtzke multiple sclerosis rating scale
Item
they have a score of 2 or higher on the expanded disability status scale (edss)
boolean
C0451246 (UMLS CUI [1])
Dementia Absent
Item
they are free from dementia as determined using the montreal cognitive assessment battery (>21) and dsm iv criteria.
boolean
C0497327 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Able to walk Treadmill
Item
they can walk on the treadmill without partial body weight support harness for 5 minutes at their preferred walking speed; this is set as the smallest bout length at the start of training.
boolean
C2712089 (UMLS CUI [1,1])
C0184069 (UMLS CUI [1,2])
Epilepsy
Item
they have no history of epileptic seizures.
boolean
C0014544 (UMLS CUI [1])
Exacerbation of multiple sclerosis
Item
they have no ms exacerbation within the preceding 4 weeks, as determined by interview and medical notes review.
boolean
C0581392 (UMLS CUI [1])
Multiple Sclerosis Therapeutic procedure Stable status | Steroids
Item
they have stable ms disease treatments (e.g., last intake of steroids occurred at least 50 days before the enrolment, ms-specific drugs stable from at least 3 months, symptomatic drugs stable from at least 1 month before the enrolment).
boolean
C0026769 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
Hearing normal | Hearing Test | Emmetropia | Snellen chart assessment
Item
they have adequate hearing (as evaluated by the whisper test and adequate vision capabilities (as measured using a snellen chart, 6.20 cut-off).
boolean
C0234725 (UMLS CUI [1])
C0018786 (UMLS CUI [2])
C0234622 (UMLS CUI [3])
C0431046 (UMLS CUI [4])
treadmill conditioning training Willing
Item
they are willing to commit to treadmill training program week and participate in all of the assessments.
boolean
C2107089 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Informed consent | Randomization Willing
Item
they provide informed written consent and are willing to be randomized to any of the 2 study arms.
boolean
C0021430 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Compliance behavior Limited
Item
they cannot follow safety or training instructions.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
nervous system disorder | Cardiovascular Diseases Unstable status | Diabetes Mellitus | Arthritis, unspecified, lower leg | Low Back Pain | Pain of lower extremities | Peripheral Neuropathy | Rheumatic disorder | Severe orthopedic problem Interferes with Walking | Mental disorders
Item
they have another neurological disorder, unstable cardiovascular disease, diabetes, lower limb arthritis, acute lower back or lower extremity pain, peripheral neuropathy, rheumatic or severe orthopaedic problems that may interfere with walking, or have diagnosed psychiatric problems.
boolean
C0027765 (UMLS CUI [1])
C0007222 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3])
C0837966 (UMLS CUI [4])
C0024031 (UMLS CUI [5])
C0239376 (UMLS CUI [6])
C0031117 (UMLS CUI [7])
C3495832 (UMLS CUI [8])
C0029354 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C0080331 (UMLS CUI [9,4])
C0004936 (UMLS CUI [10])
Pregnancy
Item
they are pregnant.
boolean
C0032961 (UMLS CUI [1])
Therapeutic procedure Investigational New Drugs | Therapeutic procedure Other
Item
they are undergoing any experimental drug or other kind of therapy.
boolean
C0087111 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Change of medication
Item
their medication regime is likely to change during the course of the study.
boolean
C0580105 (UMLS CUI [1])
Uses effective exercise program | Walking aid
Item
they are already participating in an intensive exercise program. the use of walking aids will not exclude participation.
boolean
C1820660 (UMLS CUI [1])
C0557834 (UMLS CUI [2])
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