Clinical trial NCT04616378: Design, Prototyping, and Testing of a Robotic Prosthetic Leg
Official title: Design, Prototyping, and Testing of a Robotic Prosthetic Leg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation; Traumatic, Leg, Lower
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timed up and go test
timeFrame: two weeks
Secondary outcomes:
measure: 10 meter walk test
timeFrame: one week
Other outcomes:
measure: 6 minute walk test
timeFrame: one week
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Noha Daher, DrPH
role: PRINCIPAL_INVESTIGATOR
References: