Comparison Between Three Types of Prosthetic Feet
Condition: Amputation; Traumatic, Leg, Lower, Between Knee and Ankle
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): C-SACH; B-DER; A-DER
Intervention type(s): Device; Device; Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: prosthetic feet; gait pattern; one leg standing; walking speed