Amputation; Traumatic, Leg, LowerNCT04616378
Design, Prototyping, and Testing of a Robotic Prosthetic Leg
A study testing Phase 2 Prescribed Prosthesis, Phase 2 Robotic Prosthetic Leg and Phase 3 No Prosthesis in people with Amputation; Traumatic, Leg, Lower, run by Loma Linda University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation; Traumatic, Leg, Lower
- What is being tested?
- Phase 2 Prescribed Prosthesis, Phase 2 Robotic Prosthetic Leg and Phase 3 No Prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
- Those who do not use prosthesis for walking (Level K1)
Show all 9Show fewer
- compromised skin on the residual limb (stump)
- uncontrolled swelling
- missing more than one limb
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Amputation; Traumatic, Leg, Lower
- Being tested
- Phase 2 Prescribed Prosthesis, Phase 2 Robotic Prosthetic Leg, Phase 3 No Prosthesis, Phase 3 Robotic Prosthetic Leg, Phase 3 Prescribed Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 2 Prescribed ProsthesisOther
Everyday used prosthesis that was prescribed by their physician.
Phase 2 Robotic Prosthetic LegOther
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 ProsthesisOther
No prosthetic device is attached.
Phase 3 Robotic Prosthetic LegOther
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 ProsthesisOther
Everyday used prosthesis that was prescribed by their physician.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 Prescribed Prosthesis | Other | Participants everyday use of prosthesis Receives: Other: Phase 2 Prescribed Prosthesis |
| Phase 2 Robotic Prosthetic Leg | Experimental | Robotic prosthetic leg with powered knee and passive ankle Receives: Other: Phase 2 Robotic Prosthetic Leg |
| Phase 3 Prescribed Prosthesis | Other | Participants everyday use of prosthesis Receives: Other: Phase 3 Prescribed Prosthesis |
| Phase 3 Robotic Prosthetic Leg | Experimental | Robotic prosthetic leg with powered knee and passive ankle Receives: Other: Phase 3 Robotic Prosthetic Leg |
| Phase 3 No Prosthesis | Experimental | Participant performs tasks with no prosthetic device attached Receives: Other: Phase 3 No Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: two weeks
Secondary outcomes (1)
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).
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Feb 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation; Traumatic, Leg, LowerStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noha Daher, DrPH, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616378
- Sponsor's protocol ID
- 5200345
- Status last verified
- Aug 2022
- First submitted
- 30 Oct 2020
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Prototyping, and Testing of a Robotic Prosthetic Leg
- ClinicalTrials.gov ID
- NCT04616378
- Acronym / sponsor ID
- 5200345
- Conditions
- Amputation; Traumatic, Leg, Lower
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 2 Prescribed Prosthesis | Other | Other: Phase 2 Prescribed ProsthesisParticipants everyday use of prosthesis |
| Phase 2 Robotic Prosthetic Leg | Experimental | Other: Phase 2 Robotic Prosthetic LegRobotic prosthetic leg with powered knee and passive ankle |
| Phase 3 Prescribed Prosthesis | Other | Other: Phase 3 Prescribed ProsthesisParticipants everyday use of prosthesis |
| Phase 3 Robotic Prosthetic Leg | Experimental | Other: Phase 3 Robotic Prosthetic LegRobotic prosthetic leg with powered knee and passive ankle |
| Phase 3 No Prosthesis | Experimental | Other: Phase 3 No ProsthesisParticipant performs tasks with no prosthetic device attached |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 2 Prescribed ProsthesisEveryday used prosthesis that was prescribed by their physician. | Other | Phase 2 Prescribed Prosthesis |
| Phase 2 Robotic Prosthetic LegThe 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. | Other | Phase 2 Robotic Prosthetic Leg |
| Phase 3 No ProsthesisNo prosthetic device is attached. | Other | Phase 3 No Prosthesis |
| Phase 3 Robotic Prosthetic LegThe 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. | Other | Phase 3 Robotic Prosthetic Leg |
| Phase 3 Prescribed ProsthesisEveryday used prosthesis that was prescribed by their physician. | Other | Phase 3 Prescribed Prosthesis |
Primary outcome
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).
1 secondary outcome
10 meter walk test
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha Daher, DrPH principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 2 Prescribed Prosthesis, Phase 2 Robotic Prosthetic Leg and Phase 3 No Prosthesis in people with Amputation; Traumatic, Leg, Lower, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go test (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.