NCT04616378

Design, Prototyping, and Testing of a Robotic Prosthetic Leg

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Amputation; Traumatic, Leg, Lower

Interventions

Type	Name	Description
OTHER	Phase 2 Prescribed Prosthesis	Everyday used prosthesis that was prescribed by their physician.
OTHER	Phase 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.
OTHER	Phase 3 No Prosthesis	No prosthetic device is attached.
OTHER	Phase 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.
OTHER	Phase 3 Prescribed Prosthesis	Everyday used prosthesis that was prescribed by their physician.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2020-11-05
• Last updated: 2022-08-29

Locations

1 site across 1 country: United States