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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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16 December 2017 |
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Main ID: |
NCT03046394 |
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Date of registration:
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06/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison Between Three Types of Prosthetic Feet
ProSto |
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Scientific title:
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Comparison Between Three Types of Prosthetic Feet: a Randomized Double-blind Controlled Single-subject Multiple-rater Trial |
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Date of first enrolment:
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February 6, 2017 |
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Target sample size:
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1 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03046394 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Device Feasibility. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Helena Burger, MD, 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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University Rehabilitation Institute, Republic of Slovenia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- active prosthetic foot user who walks several kilometers per day
- amputation at the trans-tibial level >5 years ago
Exclusion Criteria:
- other medical problems
Age minimum:
20 Years
Age maximum:
60 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Amputation; Traumatic, Leg, Lower, Between Knee and Ankle
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Intervention(s)
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Device: B-DER
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Device: C-SACH
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Device: A-DER
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Primary Outcome(s)
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Rating
[Time Frame: Immediately after each trial]
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Secondary Outcome(s)
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Walking velocity
[Time Frame: Immediately after the one-leg standing test]
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The time that the patient can stand on the prosthetic foot
[Time Frame: Immediately after the rating, repeated 3 times]
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Secondary ID(s)
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URIS201701
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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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