Efficiency of Hydraulic Microprocessor Prosthetic Foot for Traumatic Transtibial Amputees
Condition: Unilateral Transtibial Amputee
Study type: Interventional

Summary: 
      Background:

      Trauma is the second most common factor for transtibial amputations, just after vascular
      background. Traumatic amputees generally function better than amputees due to vascular
      background. The type of prosthetic foot fitted to the patient depends on his mobility and
      functional level, and significantly influences his stability and gait symmetry. A prosthetic
      foot with a hydraulic ankle provides significant advantages for high level functioning
      amputees: decrease of loads in the residuum, improvement in symmetry and generally gait
      pattern that is closer to natural. The hydraulic prosthetic foot has recently been upgraded
      to include computerized control over the ankle movement, using input from an array of sensors
      inside the foot. Studies have demonstrated decrease in energy consumption and gait pattern
      that is more similar to healthy people. However, hydraulic feet with and without computer
      control have not been compared. Furthermore, the effects of a computerized foot on various
      important factors have not been investigated yet, e.g. loads in the residuum, the movement of
      the center of pressure and the patient's satisfaction.

      Research objectives:

      To compare between hydraulic prosthetic feet, with and without computerized control. The
      comparison will be made while walking on flat or inclined surfaces (positive or negative
      inclination). Differences in gait parameters, loads inside the residuum, center of mass
      movement and patient's satisfaction will be quantified.

      Research hypothesis: Using a computerized prosthetic foot will provide better mobility
      performances: improved gait factors and center of pressure movement, decrease internal loads
      in the residuum and increase patient's satisfaction.

      Research design:

      Clinical controlled research with research group(amputees) and control group (healthy).
    

Detailed description: 
      The research group will perform a gait analysis test (on a computerized treadmill) using
      their own non-computerized hydraulic foot, while in-socket pressures are measured. The
      prosthetic foot will then be replaced by a computerized prosthetic foot for one month,
      following which, the measurements will be repeated. Gait factors will be examined
      (spatio-temporal data, center of pressure movement) and internal loads inside the residuum
      will be evaluated. Comparison will also include patient's satisfaction and his ability to
      move around, evaluated by dedicated questionnaire.
    

Intervention name(s): Elan foot prosthesis
Intervention type(s): Device
Intervention description(s): The research group will perform a gait analysis test (on a computerized treadmill) using their own non-computerized hydraulic foot, while in-socket pressures are measured. The prosthetic foot will then be replaced by a computerized prosthetic foot for one month, following which, the measurements will be repeated. Gait factors will be examined (spatio-temporal data, center of pressure movement) and internal loads inside the residuum will be evaluated. Comparison will also include patient's satisfaction and his ability to move around, evaluated by dedicated questionnaire.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Echeclon; Elan; TTA; Transtibial Amputee