Amputation; Traumatic, Leg, Lower
Conditions
Brief 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.
Interventions
OTHERPhase 2 Prescribed Prosthesis
Everyday used prosthesis that was prescribed by their physician.
OTHERPhase 2 Robotic Prosthetic Leg
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.
OTHERPhase 3 No Prosthesis
No prosthetic device is attached.
OTHERPhase 3 Robotic Prosthetic Leg
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.
OTHERPhase 3 Prescribed Prosthesis
Everyday used prosthesis that was prescribed by their physician.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Phase 2 Inclusion Criteria: * unilateral limb-loss. * amputation or knee disarticulation/transfemoral amputation * can walk with a variable cadence (Level K3) or play sports (Level K4) * uses a prosthesis for walking daily * can stand for 30 seconds on one limb * can follow one-step commands.
Exclusion criteria
* Those who can not walk with a variable cadence (Level K1 and K2) * compromised skin on the residual limb (stump) * uncontrolled swelling * missing more than one limb Phase 3 Inclusion Criteria: * unilateral knee disarticulation or transfemoral amputation. * can walk at a single speed (Level K2), can walk with a variable cadence (Level K3) or play sports (Level K4) * can follow one step commands.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go test | two weeks | The participant sits in a standard armchair with any assistive device used for walking nearby. The participant stands and at a self-selected walking speed, walks 3 meters, turns, and walks back to the chair, and sits down. A stopwatch records the time to of the test (in seconds). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10 meter walk test | one week | The participant will be timed as he/she walks a known distance of 10 meters to determine his/her self-selected walking velocity (distance/time). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk test | one week | This test measures distance walked in six minutes to assess the participant's physical endurance. |
Countries
United States
Outcome results
None listed