Design, Prototyping, and Testing of a Robotic Prosthetic Leg
Condition: Amputation; Traumatic, Leg, Lower
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      The purpose of this graduate student research study is to test that a specifically designed
      and novel robotic prosthetic leg (RPL) is feasible, safe and improves symmetry, efficiency,
      and metabolic function during sit-to-stand and stand-to-sit transitions as compared to the
      subject's prescribed device, and as compared to no device at all.
    

Detailed description: 
      Phase 2 case study

        -  Two subjects will be fitted with a heart rate monitor and with an adapted waist belt
           with mobile phone attached.

        -  RPL alignment will be verified.

        -  The subjects will use the RPL in parallel bars 10 times and take rests as needed in a
           chair.

        -  The subjects will perform the timed up and go test (TUGT), 10-meter walk test (10MWT),
           and the 6-minute walk test (6MWT).

        -  The subjects will be fitted with retro-reflective markers.

        -  The subjects will be fitted with a portable oxygen uptake analyzer.

        -  A 4D motion-capture camera system will be used while performing TUGT and five times sit
           to stand (5XSTS).

        -  The subjects will perform the above tests in their prescribed daily-wear prosthesis, and
           then in the RPL.

        -  The subjects will complete the activities-based balance confidence (ABC) scale test.

        -  The subjects will be asked a series of open-ended questions regarding the experience,
           while being audio recorded.

      Phase 3 pilot study

        -  Twenty subjects will be randomized into three treatment arms (no prosthesis, prescribed
           prosthesis, RPL).

        -  The subject will be fitted with a heart rate monitor.

        -  The subject will be fitted with a portable oxygen uptake analyzer.

        -  The subject will be fitted with the RPL, and the alignment of the RPL will be confirmed
           before testing.

        -  The subject will be fitted with retro-reflective markers.

        -  A 4D motion-capture camera system and force-plate will be used while performing the
           5XSTS test in the assigned randomized condition. The test will be performed three times
           in each condition.

        -  The subject will return two more times to complete the tests in the remaining randomized
           conditions, with a two-week washout period between sessions.

        -  The subject will be given the ABC scale test in the beginning and at the end of this
           study.

        -  The subject will complete the technology attitudes questionnaire (TAQ).

        -  In total, subject participation will last 1 hour per day, for three sessions, two weeks
           apart.
    

Intervention name(s): Phase 2 Prescribed Prosthesis; Phase 2 Robotic Prosthetic Leg; Phase 3 No Prosthesis; Phase 3 Robotic Prosthetic Leg; Phase 3 Prescribed Prosthesis
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Everyday used prosthesis that was prescribed by their physician.; The RPL consists of a passive-dynamic ankle, powered knee, and an on-board inertial measurement sensors with an on-board kinetic and kinematic data collection system for analysis.; No prosthetic device is attached.; The RPL consists of a passive-dynamic ankle, powered knee, and an on-board inertial measurement sensors with an on-board kinetic and kinematic data collection system for analysis.; Everyday used prosthesis that was prescribed by their physician.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other