AmputationNCT05537792
Intent Recognition for Prosthesis Control
A study testing Robotic Knee/Ankle Prosthesis in people with Amputation, run by Georgia Institute of Technology at 1 site in United States.
Trial summary
This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community ambulation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amputation
- What is being tested?
- Robotic Knee/Ankle Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 23 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A unilateral amputation of the lower limb
- Aged between 18 to 75 years, inclusive
- K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of the physiatrist and/or prosthetist)
- If a prosthesis is used, the participant must use a prosthetic knee and foot in their clinically prescribed prosthesis.
Who cannot join
- Individuals with history of neurological injury, gait pathology, or cardiovascular condition that would limit ability to ambulate for multiple hours
- Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments
Trial locations and contacts
1 site in 1 country.
United States1 site
Exoskeleton and Prosthetic Intelligent Controls Lab
Atlanta, Georgia, 30332
About this study
Official title: User-Independent Intent Recognition on a Powered Transfemoral Prosthesis
This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community ambulation. The investigators will compare the performance of the advanced algorithm with the robotic system that does not use an advanced algorithm.
Read the detailed description
The focus of this work is a proposed novel AI system to self-adapt an intent recognition system in powered prostheses to aid deployment of intent recognition systems that personalize to individual patient gait. The investigators hypothesize that the prosthesis using our self-adaptive intent recognition system will improve walking speed. Independent community ambulation is known to be more challenging for individuals with TFA, and so the investigators will measure self-selected walking speed (SSWS) which is a correlate with overall health and is a predictor of functional dependence, mobility disability and falls; furthermore, slow SSWS are correlated to lower quality of life (QOL), decreased participation and symptoms of depression. Self-adapting intent recognition has great potential to restore gait in community settings and improve embodiment, which has been associated with improved QOL and increased device usage in patients who use advanced upper limb prostheses. In this experiment, patients with TFA will be fit with our robotic knee/ankle prosthesis and proceed to walk over a treadmill and overground at varying speeds, while the investigators capture 3D biomechanics in both the self-adaptive and static user-independent system (control condition). The investigators expect the self-adaptive system to learn the best prediction of the patient's unique gait, leading to advantages in functional and patient reported outcomes over the control and baseline conditions.
- Conditions
- Amputation
- Being tested
- Robotic Knee/Ankle Prosthesis
- Keywords
- Protheses, Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Knee/Ankle ProsthesisDevice
The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
| Study group | Role | What they receive |
|---|---|---|
| Smart Robotic Knee/Ankle Prothesis | Experimental | This study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures). Receives: Device: Robotic Knee/Ankle Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overground Self-selected Walking Speed
This measures the individuals preferred overground walking speed which indicates their physical capability with a device.
Measured: 1 day
Secondary outcomes (2)
Overground Walking Speed Mean Absolute Error (MAE)
This outcome is the error with which the machine learning model embedded into our advanced prosthesis controller's microprocessor predicts the user's walking speed overground. Specifically, mean absolute error (MAE) is computed between the predicted walking speed and the ground truth walking speed, or the speed that the user is actually walking at. Ground truth measurements are measured by a motion-capture system and taken to be center of mass speed. Walking speed predictions are made every 50 ms and compared to the nearest center-of-mass speed. For this measure, lower walking speed MAEs are indicative of greater accuracy in defining the user's true walking speed and thus lower numbers are indicative of an improved outcome.
Measured: 1 day
Treadmill Walking Speed Mean Absolute Error (MAE)
This outcome is the error with which the machine learning model embedded into our advanced prosthesis controller's microprocessor predicts the user's walking speed on the treadmill. Specifically, mean absolute error (MAE) is computed between the predicted walking speed and the ground truth walking speed, or the speed that the user is actually walking at. Ground truth measurements are measured by the true treadmill speed (for treadmill trials). Walking speed predictions are made every 50 ms and compared to the nearest center-of-mass speed. For this measure, lower walking speed MAEs are indicative of greater accuracy in defining the user's true walking speed and thus lower numbers are indicative of an improved outcome.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Sep 2023
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmputationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The model used is a repeated measures single arm study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Aaron Young, Ph.D., Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537792
- Sponsor's protocol ID
- H21117
- Other IDs
- DP2HD111709
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2022
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User-Independent Intent Recognition on a Powered Transfemoral Prosthesis
- ClinicalTrials.gov ID
- NCT05537792
- Acronym / sponsor ID
- H21117
- Conditions
- Amputation
- Keywords
- Protheses, Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Posted 2 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community ambulation. The investigators will compare the performance of the advanced algorithm with the robotic system that does not use an advanced algorithm.
Detailed description
The focus of this work is a proposed novel AI system to self-adapt an intent recognition system in powered prostheses to aid deployment of intent recognition systems that personalize to individual patient gait. The investigators hypothesize that the prosthesis using our self-adaptive intent recognition system will improve walking speed. Independent community ambulation is known to be more challenging for individuals with TFA, and so the investigators will measure self-selected walking speed (SSWS) which is a correlate with overall health and is a predictor of functional dependence, mobility disability and falls; furthermore, slow SSWS are correlated to lower quality of life (QOL), decreased participation and symptoms of depression. Self-adapting intent recognition has great potential to restore gait in community settings and improve embodiment, which has been associated with improved QOL and increased device usage in patients who use advanced upper limb prostheses. In this experiment, patients with TFA will be fit with our robotic knee/ankle prosthesis and proceed to walk over a treadmill and overground at varying speeds, while the investigators capture 3D biomechanics in both the self-adaptive and static user-independent system (control condition). The investigators expect the self-adaptive system to learn the best prediction of the patient's unique gait, leading to advantages in functional and patient reported outcomes over the control and baseline conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The model used is a repeated measures single arm study.
| Arm | Type | Receives |
|---|---|---|
| Smart Robotic Knee/Ankle Prothesis | Experimental | Device: Robotic Knee/Ankle ProsthesisThis study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A unilateral amputation of the lower limb
- Aged between 18 to 75 years, inclusive
- K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of the physiatrist and/or prosthetist)
- If a prosthesis is used, the participant must use a prosthetic knee and foot in their clinically prescribed prosthesis.
Key exclusion criteria (2 listed)
- Individuals with history of neurological injury, gait pathology, or cardiovascular condition that would limit ability to ambulate for multiple hours
- Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments
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 |
|---|---|---|
| Robotic Knee/Ankle ProsthesisThe intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance. | Device | Smart Robotic Knee/Ankle Prothesis |
Primary outcome
Overground Self-selected Walking Speed
Time frame: 1 day
This measures the individuals preferred overground walking speed which indicates their physical capability with a device.
2 secondary outcomes
Overground Walking Speed Mean Absolute Error (MAE)
Time frame: 1 day
Treadmill Walking Speed Mean Absolute Error (MAE)
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Aaron Young, Ph.D. principal investigator
Georgia Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Knee/Ankle Prosthesis in people with Amputation, run by Georgia Institute of Technology 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 4 inclusion and 2 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 2 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overground Self-selected Walking Speed (time frame: 1 day). 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 2 Oct 2024.