ID

40727

Descripción

Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA); ODM derived from: https://clinicaltrials.gov/show/NCT01342458

Link

https://clinicaltrials.gov/show/NCT01342458

Palabras clave

Versiones (1)
  1. 5/5/20 5/5/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de mayo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01342458

Inglés

Eligibility Knee Osteoarthritis NCT01342458

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
kellgren and lawrence grade 2 or 3
Descripción

Kellgren-Lawrence score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3177117
being able to walk independently for at least 6 hours per day without the aid of canes or attendant to perform their activities of daily living
Descripción

Able to walk Without Cane | Able to walk Without Attendant | Able to walk hours per day | Ability Perform Activities of Daily Living

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0006856
UMLS CUI [2,1]
C2712089
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0237485
UMLS CUI [3,1]
C2712089
UMLS CUI [3,2]
C0556974
UMLS CUI [4,1]
C0085732
UMLS CUI [4,2]
C0884358
UMLS CUI [4,3]
C0001288
knee pain between 3 and 8 on the visual analogue scale
Descripción

Knee pain Visual Analog Pain Scale

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0042815
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous history of surgery on knees, ankles and hips in the last 2 years
Descripción

Operative procedure on knee | Operative procedure on ankle | Hip surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0187769
UMLS CUI [2]
C0188412
UMLS CUI [3]
C0596706
neurological disease
Descripción

Nervous system disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027765
bmi > 35 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
difference in lower limb length > 1 cm
Descripción

Leg Length Inequality Centimeter Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023221
UMLS CUI [1,2]
C0475210
UMLS CUI [1,3]
C1265611
prostheses and / or lower limb orthoses
Descripción

Prosthesis | Orthosis for lower limb

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0175649
UMLS CUI [2]
C0438865
having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively
Descripción

Injection of steroid | INTRAARTICULAR HYALURONIC ACID, Knee

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1261311
UMLS CUI [2,1]
C0493951
UMLS CUI [2,2]
C0022742
present at the knee joint instability (positive test results in the medial collateral ligament, lateral, anterior and posterior drawer)
Descripción

Instability of knee joint | Positive Test Result Medial collateral ligament | Drawer test Lateral Positive | Anterior drawer test positive | Posterior drawer test positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427262
UMLS CUI [2,1]
C1335447
UMLS CUI [2,2]
C0206367
UMLS CUI [3,1]
C0231735
UMLS CUI [3,2]
C0205093
UMLS CUI [3,3]
C1514241
UMLS CUI [4]
C0576157
UMLS CUI [5]
C0576159
oa of the hip and / or ankle incapacitating or diagnosed oa in lower limbs and spine
Descripción

Osteoarthritis of hip | Osteoarthritis of ankle | Osteoarthritis Lower Extremity | Osteoarthritis, Spine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029410
UMLS CUI [2]
C0409931
UMLS CUI [3,1]
C0029408
UMLS CUI [3,2]
C0023216
UMLS CUI [4]
C2350242
inflammatory arthritis (eg. rheumatoid arthritis)
Descripción

Arthritis | Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003873
asymptomatic oa of one or both knees
Descripción

Knee Osteoarthritis Asymptomatic | Osteoarthritis Both knees Asymptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231221
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0230434
UMLS CUI [2,3]
C0231221
dementia or inability to provide consistent information
Descripción

Dementia | Information Provide Unable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C1533716
UMLS CUI [2,2]
C1999230
UMLS CUI [2,3]
C1299582
introduction of nonsteroidal anti-inflammatory drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion
Descripción

Initiation Non-Steroidal Anti-Inflammatory Agents | Initiation Analgesics | Non-Steroidal Anti-Inflammatory Agents Dose Change | Analgesics Dose Change

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704686
UMLS CUI [1,2]
C0003211
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0002771
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0392747
UMLS CUI [4,1]
C0002771
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0392747
being under physiotherapy or acupuncture treatment
Descripción

Physical therapy | Acupuncture

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0949766
UMLS CUI [2]
C0394664
patients with an indication of prosthesis or orthosis
Descripción

Indication Prosthesis | Indication Orthosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0175649
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0029365
patients who are already using a flexible and non-heeled shoes for more than 25 hours per week (3 ½ hours per day) over the past 6 months
Descripción

Use of Adapted shoe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0563584
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Similar models

Eligibility Knee Osteoarthritis NCT01342458

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Kellgren-Lawrence score
Item
kellgren and lawrence grade 2 or 3
boolean
C3177117 (UMLS CUI [1])
Able to walk Without Cane | Able to walk Without Attendant | Able to walk hours per day | Ability Perform Activities of Daily Living
Item
being able to walk independently for at least 6 hours per day without the aid of canes or attendant to perform their activities of daily living
boolean
C2712089 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0006856 (UMLS CUI [1,3])
C2712089 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0237485 (UMLS CUI [2,3])
C2712089 (UMLS CUI [3,1])
C0556974 (UMLS CUI [3,2])
C0085732 (UMLS CUI [4,1])
C0884358 (UMLS CUI [4,2])
C0001288 (UMLS CUI [4,3])
Knee pain Visual Analog Pain Scale
Item
knee pain between 3 and 8 on the visual analogue scale
boolean
C0231749 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Operative procedure on knee | Operative procedure on ankle | Hip surgery
Item
previous history of surgery on knees, ankles and hips in the last 2 years
boolean
C0187769 (UMLS CUI [1])
C0188412 (UMLS CUI [2])
C0596706 (UMLS CUI [3])
Nervous system disorder
Item
neurological disease
boolean
C0027765 (UMLS CUI [1])
Body mass index
Item
bmi > 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Leg Length Inequality Centimeter Quantity
Item
difference in lower limb length > 1 cm
boolean
C0023221 (UMLS CUI [1,1])
C0475210 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Prosthesis | Orthosis for lower limb
Item
prostheses and / or lower limb orthoses
boolean
C0175649 (UMLS CUI [1])
C0438865 (UMLS CUI [2])
Injection of steroid | INTRAARTICULAR HYALURONIC ACID, Knee
Item
having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively
boolean
C1261311 (UMLS CUI [1])
C0493951 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
Instability of knee joint | Positive Test Result Medial collateral ligament | Drawer test Lateral Positive | Anterior drawer test positive | Posterior drawer test positive
Item
present at the knee joint instability (positive test results in the medial collateral ligament, lateral, anterior and posterior drawer)
boolean
C0427262 (UMLS CUI [1])
C1335447 (UMLS CUI [2,1])
C0206367 (UMLS CUI [2,2])
C0231735 (UMLS CUI [3,1])
C0205093 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0576157 (UMLS CUI [4])
C0576159 (UMLS CUI [5])
Osteoarthritis of hip | Osteoarthritis of ankle | Osteoarthritis Lower Extremity | Osteoarthritis, Spine
Item
oa of the hip and / or ankle incapacitating or diagnosed oa in lower limbs and spine
boolean
C0029410 (UMLS CUI [1])
C0409931 (UMLS CUI [2])
C0029408 (UMLS CUI [3,1])
C0023216 (UMLS CUI [3,2])
C2350242 (UMLS CUI [4])
Arthritis | Rheumatoid Arthritis
Item
inflammatory arthritis (eg. rheumatoid arthritis)
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
Knee Osteoarthritis Asymptomatic | Osteoarthritis Both knees Asymptomatic
Item
asymptomatic oa of one or both knees
boolean
C0409959 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0029408 (UMLS CUI [2,1])
C0230434 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
Dementia | Information Provide Unable
Item
dementia or inability to provide consistent information
boolean
C0497327 (UMLS CUI [1])
C1533716 (UMLS CUI [2,1])
C1999230 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Initiation Non-Steroidal Anti-Inflammatory Agents | Initiation Analgesics | Non-Steroidal Anti-Inflammatory Agents Dose Change | Analgesics Dose Change
Item
introduction of nonsteroidal anti-inflammatory drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion
boolean
C1704686 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C1704686 (UMLS CUI [2,1])
C0002771 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0392747 (UMLS CUI [3,3])
C0002771 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0392747 (UMLS CUI [4,3])
Physical therapy | Acupuncture
Item
being under physiotherapy or acupuncture treatment
boolean
C0949766 (UMLS CUI [1])
C0394664 (UMLS CUI [2])
Indication Prosthesis | Indication Orthosis
Item
patients with an indication of prosthesis or orthosis
boolean
C3146298 (UMLS CUI [1,1])
C0175649 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0029365 (UMLS CUI [2,2])
Use of Adapted shoe
Item
patients who are already using a flexible and non-heeled shoes for more than 25 hours per week (3 ½ hours per day) over the past 6 months
boolean
C1524063 (UMLS CUI [1,1])
C0563584 (UMLS CUI [1,2])
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