ID

30829

Beschreibung

Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00872053

Link

https://clinicaltrials.gov/show/NCT00872053

Stichworte

Versionen (2)
  1. 25.06.18 25.06.18 -
  2. 25.06.18 25.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Juni 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility MS (Multiple Sclerosis) NCT00872053

Englisch

Eligibility MS (Multiple Sclerosis) NCT00872053

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Multiple Sclerosis EDSS | Difficulty walking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0451246
UMLS CUI [2]
C0311394
presence of unilateral foot drop that is clinically apparent to the pi or pi designate.
Beschreibung

Foot-drop Unilateral

Datentyp

boolean

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

Able to walk Feet Quantity | Absence Device Assistance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0347981
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0699733
UMLS CUI [2,3]
C1269765
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiovascular: recent mi < 4 wk, uncontrolled htn >190/110 mmhg.
Beschreibung

Exclusion Criteria Cardiovascular | Myocardial Infarction | Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3887460
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1868885
history of uncontrolled diabetes.
Beschreibung

Diabetic - poor control

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
symptoms of orthostasis when standing up.
Beschreibung

Symptoms Orthostasis Standing up

Datentyp

boolean

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

Circulation problem | Claudication Vascular | Pitting edema

Datentyp

boolean

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

Comprehension Study Protocol Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1299582
body weight over 150 kg.
Beschreibung

Body Weight

Datentyp

boolean

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

Leg Injuries | Limitation of joint movement | Limited function

Datentyp

boolean

Alias
UMLS CUI [1]
C0023220
UMLS CUI [2]
C0231589
UMLS CUI [3]
C0497533
joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
Beschreibung

Joint problem Hip | Joint problem Leg | Limitation of joint movement | Movement pain | Therapeutic procedure Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0575044
UMLS CUI [1,2]
C0019552
UMLS CUI [2,1]
C0575044
UMLS CUI [2,2]
C1140621
UMLS CUI [3]
C0231589
UMLS CUI [4]
C0240386
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1272705
unstable fractures.
Beschreibung

Unstable fracture

Datentyp

boolean

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

Pressure sores | Broken skin | Other Coding

Datentyp

boolean

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

Substance Use Disorders chronic

Datentyp

boolean

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

Premorbidity | Depressive disorder | Psychotic Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0871122
UMLS CUI [2]
C0011581
UMLS CUI [3]
C0033975
ongoing physical therapy.
Beschreibung

Physical therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0949766
pregnancy (self-reported)
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
pi's determination of inability to complete the test protocol
Beschreibung

Test protocol Completion Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449876
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
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Ähnliche Modelle

Eligibility MS (Multiple Sclerosis) NCT00872053

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis EDSS | Difficulty walking
Item
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])
C0311394 (UMLS CUI [2])
Foot-drop Unilateral
Item
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 Feet Quantity | Absence Device Assistance
Item
must be able to ambulate 25 feet without an assisting device.
boolean
C2712089 (UMLS CUI [1,1])
C0347981 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0699733 (UMLS CUI [2,2])
C1269765 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Cardiovascular | Myocardial Infarction | Uncontrolled hypertension
Item
cardiovascular: recent mi < 4 wk, uncontrolled htn >190/110 mmhg.
boolean
C0680251 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
Diabetic - poor control
Item
history of uncontrolled diabetes.
boolean
C0421258 (UMLS CUI [1])
Symptoms Orthostasis Standing up
Item
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
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])
Comprehension Study Protocol Unable
Item
unable to fully understand instructions in order to use the equipment or the process of the study.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Body Weight
Item
body weight over 150 kg.
boolean
C0005910 (UMLS CUI [1])
Leg Injuries | Limitation of joint movement | Limited function
Item
lower extremity injuries that limit range of motion or function.
boolean
C0023220 (UMLS CUI [1])
C0231589 (UMLS CUI [2])
C0497533 (UMLS CUI [3])
Joint problem Hip | Joint problem Leg | Limitation of joint movement | Movement pain | Therapeutic procedure Unsuccessful
Item
joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
boolean
C0575044 (UMLS CUI [1,1])
C0019552 (UMLS CUI [1,2])
C0575044 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C0231589 (UMLS CUI [3])
C0240386 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
Unstable fracture
Item
unstable fractures.
boolean
C0559876 (UMLS CUI [1])
Pressure sores | Broken skin | Other Coding
Item
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
chronic and ongoing alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Premorbidity | Depressive disorder | Psychotic Disorders
Item
pre-morbid, ongoing depression or psychosis.
boolean
C0871122 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
Physical therapy
Item
ongoing physical therapy.
boolean
C0949766 (UMLS CUI [1])
Pregnancy
Item
pregnancy (self-reported)
boolean
C0032961 (UMLS CUI [1])
Test protocol Completion Unable
Item
pi's determination of inability to complete the test protocol
boolean
C0449876 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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