Design, Prototyping, and Testing of a Robotic Prosthetic Leg

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Traumatic, Leg, Lower
• Intervention / Treatment: Other: Phase 2 Prescribed Prosthesis; Other: Phase 2 Robotic Prosthetic Leg; Other: Phase 3 Prescribed Prosthesis; Other: Phase 3 Robotic Prosthetic Leg; Other: Phase 3 No Prosthesis

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Phase 2 Prescribed Prosthesis; Participants everyday use of prosthesis	Other: Phase 2 Prescribed Prosthesis; Everyday used prosthesis that was prescribed by their physician.
Experimental: Phase 2 Robotic Prosthetic Leg; Robotic prosthetic leg with powered knee and passive ankle	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 Prescribed Prosthesis; Participants everyday use of prosthesis	Other: Phase 3 Prescribed Prosthesis; Everyday used prosthesis that was prescribed by their physician.
Experimental: Phase 3 Robotic Prosthetic Leg; Robotic prosthetic leg with powered knee and passive ankle	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.
Experimental: Phase 3 No Prosthesis; Participant performs tasks with no prosthetic device attached	Other: Phase 3 No Prosthesis; No prosthetic device is attached.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go test	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).	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 meter walk test	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).	one week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	This test measures distance walked in six minutes to assess the participant's physical endurance.	one week

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Noha Daher, DrPH, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: 5200345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No