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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616378
• Other study ID #: 5200345
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: August 2022
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Phase 2 Prescribed Prosthesis
Everyday used prosthesis that was prescribed by their physician.
• 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.
• Phase 3 No Prosthesis
No prosthetic device is attached.
• 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.
• Phase 3 Prescribed Prosthesis
Everyday used prosthesis that was prescribed by their physician.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	6 minute walk test	This test measures distance walked in six minutes to assess the participant's physical endurance.	one week
Primary	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	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