ID

15590

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02427997

Palabras clave

Versiones (1)
  1. 4/6/16 4/6/16 -
Subido en

4 de junio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Multiple Sclerosis NCT02427997

Inglés

Eligibility Multiple Sclerosis NCT02427997

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

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

Tipo de datos

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)
Descripción

Kurtzke multiple sclerosis rating scale

Tipo de datos

boolean

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

Dementia Absent

Tipo de datos

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.
Descripción

Able to walk Treadmill

Tipo de datos

boolean

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

Epilepsy

Tipo de datos

boolean

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

Exacerbation of multiple sclerosis

Tipo de datos

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).
Descripción

Multiple Sclerosis Therapeutic procedure Stable status | Steroids

Tipo de datos

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).
Descripción

Hearing normal | Hearing Test | Emmetropia | Snellen chart assessment

Tipo de datos

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.
Descripción

treadmill conditioning training Willing

Tipo de datos

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.
Descripción

Informed consent | Randomization Willing

Tipo de datos

boolean

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

Exclusion Criteria

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

Compliance behavior Limited

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Pregnancy

Tipo de datos

boolean

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

Therapeutic procedure Investigational New Drugs | Therapeutic procedure Other

Tipo de datos

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.
Descripción

Change of medication

Tipo de datos

boolean

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

Uses effective exercise program | Walking aid

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1820660
UMLS CUI [2]
C0557834
Volver a la parte superior de la página

Similar models

Eligibility Multiple Sclerosis NCT02427997

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial