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Main
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Note: This record shows only 22 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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01415219 |
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Date of registration:
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08/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
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Scientific title:
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Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01415219 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Andre Thevenon, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Lille |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosis of Dermatomyositis ore polymyositis according to the International Myositis
Assessment and Clinical Studies Group
- functional impairment (an HAQ score greater than 0.5)
- stability of muscle impairment
- medical insurance
Exclusion Criteria:
- no recent inflammatory activity
- other chronic disease
- cognitive impairment
- patients who participated to a rehabilitation program before inclusion
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dermatomyositis
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Polymyositis
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Intervention(s)
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Other: Active rehabilitation
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Primary Outcome(s)
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HAQ score
[Time Frame: 6 month and 1 year after rehabilitation]
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Secondary Outcome(s)
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MFM(motor function measure)
[Time Frame: 6 month and one year after rehabilitation]
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Quality of life (SF36 score)
[Time Frame: 6 month and 1 year after rehabilitation]
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muscle strength (MRC manual muscle testing)
[Time Frame: at 6 month and one year after rehabilitation]
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Secondary ID(s)
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DGS 2007-0440
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2007-A00756-47
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PHRC 2006/1916
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2007_0712
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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