Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2017-02-06
2017-05-03
Brief Summary
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Detailed Description
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All the prosthetic feet are of the same size and chosen for the patient's weight. They will be covered so that neither the patient nor professionals will be able to see which prosthetic foot is being used.
The study is blinded because the prosthetist designated for changing the prosthetic feet will be the only one who will know which prosthetic is being used. The orientational sample size calculation and the randomisation plan were prepared by a statistician.
The first trial will be performed using the patient's own prosthetic foot in order to establish a baseline. The patient will then have to to compare the prosthetic feet with his own existing prosthetic foot and rate the ability to walk on even terrain (100m), uneven terrain (grass, 100m), decline and incline (i.e., slope), and up and down the stairs (one floor) on a five-point Likert-type scale (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better). After each trial he will also perform the one-leg standing test (with three repetitions) and the 10-meter walking test. Before each trial, the patient will be given 15 minutes for adaptation to each new prosthetic foot without the presence of the assessors.
The three expert observers will be: a physical and rehabilitation medicine specialist physician, a certified prosthetist-orthotist, and a physiotherapist. Each has got over 20 years of experience in rehabilitation of patients after amputation and observation of their gait. They will be blind to the currently used prosthetic foot. They will follow the patient and assess his walking using the same rating scale in comparison with the initial trial as the patient.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DEVICE_FEASIBILITY
TRIPLE
Study Groups
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C-SACH
All the interventions will be administered to the patient in this single-subject trial, each 6 times
C-SACH
Solid Ankle Cushion Heel by Otto Bock, advertised for activity category 1
B-DER
All the interventions will be administered to the patient in this single-subject trial, each 6 times
B-DER
Dynamic Motion by Otto Bock, advertised for activity category 2-3
A-DER
All the interventions will be administered to the patient in this single-subject trial, each 6 times
A-DER
Triton by Otto Bock, advertised for activity category 3-4
Interventions
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C-SACH
Solid Ankle Cushion Heel by Otto Bock, advertised for activity category 1
B-DER
Dynamic Motion by Otto Bock, advertised for activity category 2-3
A-DER
Triton by Otto Bock, advertised for activity category 3-4
Eligibility Criteria
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Inclusion Criteria
* amputation at the trans-tibial level \>5 years ago
Exclusion Criteria
20 Years
60 Years
MALE
No
Sponsors
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University Rehabilitation Institute, Republic of Slovenia
OTHER
Responsible Party
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Principal Investigators
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Helena Burger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Rehabilitation Institute, Republic of Slovenia
Locations
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University Rehabilitation Institute, Republic of Slovenia
Ljubljana, , Slovenia
Countries
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Other Identifiers
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URIS201701
Identifier Type: -
Identifier Source: org_study_id
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