Design, Prototyping, and Testing of a Robotic Prosthetic Leg

Amputation; Traumatic, Leg, Lower Clinical Trial

Official title: Design, Prototyping, and Testing of a Robotic Prosthetic Leg

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Leg, Lower

• NCT number: NCT04616378
• Study type: Interventional
• Source: Loma Linda University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Completion date: March 30, 2022