ID

30944

Beskrivning

Targeted Lower Extremity Joint Training; ODM derived from: https://clinicaltrials.gov/show/NCT00765544

Länk

https://clinicaltrials.gov/show/NCT00765544

Nyckelord

Versioner (1)
  1. 2018-07-05 2018-07-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00765544

Engelsk

Eligibility Multiple Sclerosis NCT00765544

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. clinical diagnosis of ms by mcdonald criteria (mcdonald, compston et al. 2001). edss level between 3.5-5.5, who report ambulation problems.
Beskrivning

Multiple Sclerosis EDSS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0451246
2. men and women between the ages 18-75 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. presence of unilateral foot drop that is clinically apparent to the pi or pi designate.
Beskrivning

Foot-drop Unilateral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085684
UMLS CUI [1,2]
C0205092
4. must be able to ambulate 25 feet without an assisting device
Beskrivning

Able to walk Without Walking aid | Able to walk Feet Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0557834
UMLS CUI [2,1]
C2712089
UMLS CUI [2,2]
C0347981
UMLS CUI [2,3]
C1265611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. cardiovascular: recent mi < 4 wk, uncontrolled htn >190/110 mmhg, history of uncontrolled diabetes.
Beskrivning

Exclusion Criteria Cardiovascular | Myocardial Infarction | Uncontrolled hypertension | Diabetic - poor control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3887460
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0421258
2. symptoms of orthostasis when standing up.
Beskrivning

Symptoms Orthostasis Standing up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0149746
UMLS CUI [1,3]
C0444796
3. circulatory problems, history of vascular claudication or pitting edema.
Beskrivning

Circulation problem | Claudication Vascular | Pitting edema

Datatyp

boolean

Alias
UMLS CUI [1]
C0848724
UMLS CUI [2,1]
C1456822
UMLS CUI [2,2]
C1801960
UMLS CUI [3]
C0333243
4. unable to fully understand instructions in order to use the equipment or the process of the study.
Beskrivning

Instructions Comprehension Unable | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1442085
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
5. body weight over 150 kg.
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
6. lower extremity injuries that limit range of motion or function.
Beskrivning

Leg Injuries Limitation of joint movement | Leg Injuries Limited function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023220
UMLS CUI [1,2]
C0231589
UMLS CUI [2,1]
C0023220
UMLS CUI [2,2]
C1331405
7. joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
Beskrivning

Joint problem Limitation of joint movement | Joint problem Causing Movement pain | Hip Joint Problem | Joint of lower extremity Problem | Treatment Resistant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0575044
UMLS CUI [1,2]
C0231589
UMLS CUI [2,1]
C0575044
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0240386
UMLS CUI [3,1]
C0019558
UMLS CUI [3,2]
C0033213
UMLS CUI [4,1]
C0584731
UMLS CUI [4,2]
C0033213
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0332325
8. unstable fractures.
Beskrivning

Unstable fracture

Datatyp

boolean

Alias
UMLS CUI [1]
C0559876
9. pressure sores with any skin breakdown in areas in contact with the body harness or lokomat apparatus.
Beskrivning

Pressure Ulcer | Broken skin | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C0011127
UMLS CUI [2]
C0150077
UMLS CUI [3]
C3846158
10. chronic and ongoing alcohol or drug abuse.
Beskrivning

Substance Use Disorders chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0205191
11. pre-morbid, ongoing depression or psychosis.
Beskrivning

Premorbidity Depressive disorder | Premorbidity Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871122
UMLS CUI [1,2]
C0011581
UMLS CUI [2,1]
C0871122
UMLS CUI [2,2]
C0033975
12. ongoing physical therapy.
Beskrivning

Physical therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0949766
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Similar models

Eligibility Multiple Sclerosis NCT00765544

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis EDSS
Item
1. clinical diagnosis of ms by mcdonald criteria (mcdonald, compston et al. 2001). edss level between 3.5-5.5, who report ambulation problems.
boolean
C0026769 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Age
Item
2. men and women between the ages 18-75 years.
boolean
C0001779 (UMLS CUI [1])
Foot-drop Unilateral
Item
3. presence of unilateral foot drop that is clinically apparent to the pi or pi designate.
boolean
C0085684 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Able to walk Without Walking aid | Able to walk Feet Quantity
Item
4. must be able to ambulate 25 feet without an assisting device
boolean
C2712089 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0557834 (UMLS CUI [1,3])
C2712089 (UMLS CUI [2,1])
C0347981 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Cardiovascular | Myocardial Infarction | Uncontrolled hypertension | Diabetic - poor control
Item
1. cardiovascular: recent mi < 4 wk, uncontrolled htn >190/110 mmhg, history of uncontrolled diabetes.
boolean
C0680251 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
Symptoms Orthostasis Standing up
Item
2. symptoms of orthostasis when standing up.
boolean
C1457887 (UMLS CUI [1,1])
C0149746 (UMLS CUI [1,2])
C0444796 (UMLS CUI [1,3])
Circulation problem | Claudication Vascular | Pitting edema
Item
3. circulatory problems, history of vascular claudication or pitting edema.
boolean
C0848724 (UMLS CUI [1])
C1456822 (UMLS CUI [2,1])
C1801960 (UMLS CUI [2,2])
C0333243 (UMLS CUI [3])
Instructions Comprehension Unable | Protocol Compliance Unable
Item
4. unable to fully understand instructions in order to use the equipment or the process of the study.
boolean
C1442085 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Body Weight
Item
5. body weight over 150 kg.
boolean
C0005910 (UMLS CUI [1])
Leg Injuries Limitation of joint movement | Leg Injuries Limited function
Item
6. lower extremity injuries that limit range of motion or function.
boolean
C0023220 (UMLS CUI [1,1])
C0231589 (UMLS CUI [1,2])
C0023220 (UMLS CUI [2,1])
C1331405 (UMLS CUI [2,2])
Joint problem Limitation of joint movement | Joint problem Causing Movement pain | Hip Joint Problem | Joint of lower extremity Problem | Treatment Resistant
Item
7. joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
boolean
C0575044 (UMLS CUI [1,1])
C0231589 (UMLS CUI [1,2])
C0575044 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0240386 (UMLS CUI [2,3])
C0019558 (UMLS CUI [3,1])
C0033213 (UMLS CUI [3,2])
C0584731 (UMLS CUI [4,1])
C0033213 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0332325 (UMLS CUI [5,2])
Unstable fracture
Item
8. unstable fractures.
boolean
C0559876 (UMLS CUI [1])
Pressure Ulcer | Broken skin | Other Coding
Item
9. pressure sores with any skin breakdown in areas in contact with the body harness or lokomat apparatus.
boolean
C0011127 (UMLS CUI [1])
C0150077 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Substance Use Disorders chronic
Item
10. chronic and ongoing alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Premorbidity Depressive disorder | Premorbidity Psychotic Disorders
Item
11. pre-morbid, ongoing depression or psychosis.
boolean
C0871122 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
C0871122 (UMLS CUI [2,1])
C0033975 (UMLS CUI [2,2])
Physical therapy
Item
12. ongoing physical therapy.
boolean
C0949766 (UMLS CUI [1])
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