Design, Prototyping, and Testing of a Robotic Prosthetic Leg

Not Applicable

Completed

• Conditions: Amputation; Traumatic, Leg, Lower
• Interventions: Other: Phase 3 Prescribed Prosthesis; Other: Phase 3 No Prosthesis; Other: Phase 2 Prescribed Prosthesis; Other: Phase 2 Robotic Prosthetic Leg; Other: Phase 3 Robotic Prosthetic Leg

• Registration Number: NCT04616378
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-05
• Study Start: 2021-02-01
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

Exclusion Criteria:

• Those who do not use prosthesis for walking (Level K1)
• compromised skin on the residual limb (stump)
• uncontrolled swelling
• missing more than one limb

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 3 Prescribed Prosthesis	Phase 3 Prescribed Prosthesis	Participants everyday use of prosthesis
Phase 3 No Prosthesis	Phase 3 No Prosthesis	Participant performs tasks with no prosthetic device attached
Phase 2 Prescribed Prosthesis	Phase 2 Prescribed Prosthesis	Participants everyday use of prosthesis
Phase 2 Robotic Prosthetic Leg	Phase 2 Robotic Prosthetic Leg	Robotic prosthetic leg with powered knee and passive ankle
Phase 3 Robotic Prosthetic Leg	Phase 3 Robotic Prosthetic Leg	Robotic prosthetic leg with powered knee and passive ankle

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States