An interventional study of C-SACH and B-DER in Amputation; Traumatic, Leg, Lower, Between Knee and Ankle, sponsored by University Rehabilitation Institute, Republic of Slovenia. Completed at 1 site in Slovenia. Open to male participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-05-04.
Sponsored by University Rehabilitation Institute, Republic of Slovenia · Not applicable, Interventional, and Device feasibility
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.
The prosthetic feet will be: one SACH foot (by Otto Bock - foot C, advertised for activity category 1) and two DER feet (Dynamic Motion by Otto Bock - foot B, advertised for activity category 2-3; and Triton by Otto Bock - foot A, advertised for activity category 3-4).
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.
101 studies on the registry are indexed under Amputation, Traumatic; 14 are open to participants now.
This study's enrollment of 1 is below the median of 13 across 68 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →University Rehabilitation Institute, Republic of Slovenia is the lead sponsor of 21 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All the interventions will be administered to the patient in this single-subject trial, each 6 times
Device: C-SACH
All the interventions will be administered to the patient in this single-subject trial, each 6 times
Device: B-DER
All the interventions will be administered to the patient in this single-subject trial, each 6 times
Device: A-DER
Solid Ankle Cushion Heel by Otto Bock, advertised for activity category 1
Dynamic Motion by Otto Bock, advertised for activity category 2-3
Triton by Otto Bock, advertised for activity category 3-4
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)
Time frame: Immediately after each trial
The time that the patient can stand on the prosthetic foot
Measured by the one-leg standing test (average of three repetitions)
Time frame: Immediately after the rating, repeated 3 times
Walking velocity
Measured by the 10-meter walking test
Time frame: Immediately after the one-leg standing test
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Rehabilitation Institute, Republic of Slovenia