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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: |
NCT01586663 |
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Date of registration:
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25/04/2012 |
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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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Serial Night Time Position Splint on Systemic Sclerosis
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Scientific title:
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Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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76 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01586663 |
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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 (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Fernanda P Cardoso, OT |
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Address:
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Telephone:
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551155764239 |
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Email:
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anamajones@gmail.com |
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Affiliation:
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Name:
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Fernanda P Cardosos, OT |
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Address:
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Telephone:
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551155764239 |
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Email:
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anamajones@gmail.com |
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Affiliation:
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Name:
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Jamil Natour, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of São Paulo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diffuse Systemic scleroses diagnosed following the ACR criteria
- Older than 18 years old
- Sclerodactyly
Exclusion Criteria:
- Neurological, psychiatric diseases and other rheumatic disease (including
overlapping)
- Previous use of splints or allergy to splint material
- Surgery schedule to the next 12 months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diffuse Systemic Sclerosis
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Intervention(s)
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Device: Serial night time position splint
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Drug: Drug treatment
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Primary Outcome(s)
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Change in hand range of motion
[Time Frame: Baseline and after 3, 6, 9 and 12 months]
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Secondary Outcome(s)
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Change in quality of life
[Time Frame: Basline, after 10, 20 and 40 weeks]
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Change in functional capacity
[Time Frame: Baseline, after 10, 20 and 40 weeks]
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Change in upper limb function
[Time Frame: Baseline, after 10, 20 and 40 weeks]
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Change in pain
[Time Frame: Baseline, after 10, 20 and 40 weeks]
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Change in dexterity
[Time Frame: Baseline, after 3, 6, 9 and 12 months]
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Secondary ID(s)
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CEP 1070/09
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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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