NCT03046394|CompletedDMC
Comparison Between Three Types of Prosthetic Feet
ProSto
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ProSto
Sponsor study identifier
interventional
1
1 country
1
Study Start
February 6, 2017
Actual (reported)Primary Completion
February 10, 2017
Actual (reported)Study Completion
May 3, 2017
Actual (reported)One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. One-leg standing and 10-meter walking tests will also be performed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 3, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 6, 2017
Actual (reported)February 6, 2017
Actual (reported)February 8, 2017
Actual (reported)February 10, 2017
Actual (reported)May 3, 2017
Actual (reported)Rating
Likert-type, compared to the patient's existing prosthetic foot (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better)
Immediately after each trial
The time that the patient can stand on the prosthetic foot
Immediately after the rating, repeated 3 times
Walking velocity
Immediately after the one-leg standing test
All the interventions will be administered to the patient in this single-subject trial, each 6 times
All the interventions will be administered to the patient in this single-subject trial, each 6 times
All the interventions will be administered to the patient in this single-subject trial, each 6 times
Solid Ankle Cushion Heel by Otto Bock, advertised for activity category 1
Dynamic Motion by Otto Bock, advertised for activity category 2-3
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000, Slovenia
Helena Burger, MD, PhD
University Rehabilitation Institute, Republic of Slovenia
1 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2017
First Posted
February 8, 2017
Study Start
February 6, 2017
Actual (reported)Triton by Otto Bock, advertised for activity category 3-4
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 10, 2017
Actual (reported)Study Completion
May 3, 2017
Actual (reported)Last Updated
May 4, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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