Design, Prototyping, and Testing of a Robotic Prosthetic Leg
NCT ID: NCT04616378
Last Updated: 2022-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2 participants
INTERVENTIONAL
2021-02-01
2022-03-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Phase 2 Prescribed Prosthesis
Participants everyday use of prosthesis
Phase 2 Prescribed Prosthesis
Everyday used prosthesis that was prescribed by their physician.
Phase 2 Robotic Prosthetic Leg
Robotic prosthetic leg with powered knee and passive ankle
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 Prescribed Prosthesis
Participants everyday use of prosthesis
Phase 3 Prescribed Prosthesis
Everyday used prosthesis that was prescribed by their physician.
Phase 3 Robotic Prosthetic Leg
Robotic prosthetic leg with powered knee and passive ankle
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 No Prosthesis
Participant performs tasks with no prosthetic device attached
Phase 3 No Prosthesis
No prosthetic device is attached.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* compromised skin on the residual limb (stump)
* uncontrolled swelling
* missing more than one limb
Phase 3
* Those who do not use prosthesis for walking (Level K1)
* compromised skin on the residual limb (stump)
* uncontrolled swelling
* missing more than one limb
18 Years
65 Years
ALL
Yes
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Noha Daher, DrPH
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University
Loma Linda, California, United States
Countries
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Other Identifiers
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5200345
Identifier Type: -
Identifier Source: org_study_id
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