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Design, Prototyping, and Testing of a Robotic Prosthetic Leg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04616378
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amputation; Traumatic, Leg, Lower Other: Phase 2 Prescribed Prosthesis Other: Phase 2 Robotic Prosthetic Leg Other: Phase 3 No Prosthesis Other: Phase 3 Robotic Prosthetic Leg Other: Phase 3 Prescribed Prosthesis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Design, Prototyping, and Testing of a Robotic Prosthetic Leg
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Timed up and go test [ Time Frame: two weeks ]
    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).


Secondary Outcome Measures :
  1. 10 meter walk test [ Time Frame: one week ]
    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).


Other Outcome Measures:
  1. 6 minute walk test [ Time Frame: one week ]
    This test measures distance walked in six minutes to assess the participant's physical endurance.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04616378


Contacts
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Contact: Noha Daher, DrPH 909-558-4000 ext 47678 ndaher@llu.edu
Contact: Michael Davidson, MSE MPH 909-558-4000 ext 66516 mdavidson@llu.edu

Locations
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United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92354
Contact: Noha Daher, DrPH    909-558-4000 ext 67478    ndaher@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Noha Daher, DrPH Loma Linda University
More Information
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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT04616378    
Other Study ID Numbers: 5200345
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amputation, Traumatic
Wounds and Injuries