Design, Prototyping, and Testing of a Robotic Prosthetic Leg
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2020
CompletedFirst Posted
Study publicly available on registry
November 5, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedAugust 29, 2022
August 1, 2022
1.2 years
October 30, 2020
August 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
10 meter walk test
one week
Other Outcomes (1)
6 minute walk test
one week
Study Arms (5)
Phase 2 Prescribed Prosthesis
OTHERParticipants everyday use of prosthesis
Phase 2 Robotic Prosthetic Leg
EXPERIMENTALRobotic prosthetic leg with powered knee and passive ankle
Phase 3 Prescribed Prosthesis
OTHERParticipants everyday use of prosthesis
Phase 3 Robotic Prosthetic Leg
EXPERIMENTALRobotic prosthetic leg with powered knee and passive ankle
Phase 3 No Prosthesis
EXPERIMENTALParticipant performs tasks with no prosthetic device attached
Interventions
Everyday used prosthesis that was prescribed by their physician.
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.
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.
Everyday used prosthesis that was prescribed by their physician.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- Those who do not use prosthesis for walking (Level K1)
- compromised skin on the residual limb (stump)
- uncontrolled swelling
- missing more than one limb
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda University
Loma Linda, California, 92354, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Noha Daher, DrPH
Loma Linda University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2020
First Posted
November 5, 2020
Study Start
February 1, 2021
Primary Completion
March 30, 2022
Study Completion
March 30, 2022
Last Updated
August 29, 2022
Record last verified: 2022-08