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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR609 |
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Date of registration:
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07/02/2006 |
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Primary sponsor: |
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Public title:
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Patients with Chronic Idiopathic Axonal Polyneuropathy (CIAP): Relationships in the Disablement Process.
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Scientific title:
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Patients with Chronic Idiopathic Axonal Polyneuropathy (CIAP): Relationships in the Disablement Process. - EXAMPLE Part II |
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Date of first enrolment:
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1/3/2006 |
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Target sample size:
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90 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=609 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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N.L.U.
Meeteren, van |
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Address:
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University Medical Center Utrecht, Department of Neurology and Neurosurgery, Rudolf Magnus Institute of Neuroscience,
P.O. Box 85500
3508 GA
Utrecht
The Netherlands |
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Telephone:
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Email:
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n.vanmeeteren@umcutrecht.nl |
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Affiliation:
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Name:
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N.L.U.
Meeteren, van |
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Address:
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University Medical Center Utrecht, Department of Neurology and Neurosurgery, Rudolf Magnus Institute of Neuroscience,
P.O. Box 85500
3508 GA
Utrecht
The Netherlands |
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Telephone:
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Email:
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n.vanmeeteren@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with CIAP, diagnosed on established criteria;
2. Dutch written and spoken language;
3. Signed informed consent.
Exclusion criteria: 1. Relevant co-morbidity, expected to influence the test results;
2. Anticipated health risks during performance-based testing.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Chronic Idiopathic Axonal Polyneuropathy (CIAP)
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Intervention(s)
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None: longitudinal study with one patientgroup with CIAP in which the healthstatus will be monitored.
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Primary Outcome(s)
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Parameters of four domains of the Disablement Process will be measured:
Impairment: muscle strength (hand-held dynamometry), balance (Berg Balance Scale), sensory function (sensory modality score), pain (McGill pain questionnaire), fatigue (Fatigue Severity Scale).
Functional limitations: walking (modified Shuttle Walk Test), physical functioning (Physical Functioning Performance 10 Test), hand functioning (buttontest and Disabilities of the Arm, Shoulder, and Hand questionnaire), physical activity (DigiWalker Stepcounter), problematic activities (McMaster-Toronto Arthritis patient function preference questionnaire),
Disability: autonomy and participation (Impact on Participation and Autonomy questionnaire and Rankin score).
Intra-individual risk factor: cognitions; intentions and perceptions of control (TPB questionnaire ), emotions (Hospital anxiety and depression scale).
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Secondary ID(s)
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2006-01
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ISRCTN29920470
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Source(s) of Monetary Support
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University Medical Center Utrecht (UMCU), Department of Rehabilitation
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