AmputationNCT06468059
Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
A study testing Layered Low Profile Foot and Prescribed Ankle in people with Amputation, run by Little Room Innovations, LLC at 1 site in United States.
Trial summary
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amputation
- What is being tested?
- Layered Low Profile Foot and Prescribed Ankle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 16 Jul 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-89 years old
- unilateral transtibial amputation
- daily use of a low profile foot
- cognitive ability to understand and willingness to provide informed consent and follow the study protocol
Who cannot join
- unable to perform walking for 2 minutes without an assistive device
- other health conditions which may prevent them from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.
- Conditions
- Amputation
- Being tested
- Layered Low Profile Foot, Prescribed Ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Layered Low Profile FootDevice
Also called LPF
The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.
Prescribed AnkleDevice
Also called Daily Use Prosthesis
The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
| Study group | Role | What they receive |
|---|---|---|
| Layered Low Profile Foot (LPF) vs. Prescribed Ankle | Experimental | In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle. Receives: Device: Layered Low Profile Foot; Device: Prescribed Ankle |
| Prescribed Ankle vs. Layered Low Profile Foot (LPF) | Experimental | In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF. Receives: Device: Layered Low Profile Foot; Device: Prescribed Ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Energy Stored (TES)
TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.
Measured: through study completion, an average of 1 day
Secondary outcomes (3)
Ankle Quasi-Stiffness (AQS)
AQS is a measure of joint deformation under an applied load. It is extracted from the torque-angle relationship during walking determined through inverse dynamics. The ideal AQS varies from person to person, but in this study we were interested in seeing if the prostheses could achiever lower AQS.
Measured: through study completion, an average of 1 day
Walking Speed
This is the linear rate of change of position when a person walks, typically given in m/s.
Measured: through study completion, an average of 1 day
Likert Scale Rating of Device Satisfaction
A 1 to 10 rating of device satisfaction where the pre-trial perceived device satisfaction of the participant's prescribed ankle is defined as a 5 out of 10. 1 is defined as completely unacceptable, and 10 is defined as ideal performance.
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start21 Mar 2024
- Primary completion16 Jul 2024
- Study completion16 Jul 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Little Room Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kennesaw State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468059
- Sponsor's protocol ID
- R43HD110316
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2024
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
- ClinicalTrials.gov ID
- NCT06468059
- Acronym / sponsor ID
- R43HD110316
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Little Room Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Kennesaw State University
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Posted 17 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Layered Low Profile Foot (LPF) vs. Prescribed Ankle | Experimental | Device: Layered Low Profile Foot, Device: Prescribed AnkleIn this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle. |
| Prescribed Ankle vs. Layered Low Profile Foot (LPF) | Experimental | Device: Layered Low Profile Foot, Device: Prescribed AnkleIn this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-89 years old
- unilateral transtibial amputation
- daily use of a low profile foot
- cognitive ability to understand and willingness to provide informed consent and follow the study protocol
Key exclusion criteria (2 listed)
- unable to perform walking for 2 minutes without an assistive device
- other health conditions which may prevent them from participating in the study
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 |
|---|---|---|
| Layered Low Profile FootAlso: LPFThe layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength. | Device | Layered Low Profile Foot (LPF) vs. Prescribed Ankle, Prescribed Ankle vs. Layered Low Profile Foot (LPF) |
| Prescribed AnkleAlso: Daily Use ProsthesisThe prescribed ankle is the prosthetic ankle that the subject wears for daily use. | Device | Layered Low Profile Foot (LPF) vs. Prescribed Ankle, Prescribed Ankle vs. Layered Low Profile Foot (LPF) |
Primary outcome
Total Energy Stored (TES)
Time frame: through study completion, an average of 1 day
TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.
3 secondary outcomes
Ankle Quasi-Stiffness (AQS)
Time frame: through study completion, an average of 1 day
Walking Speed
Time frame: through study completion, an average of 1 day
Likert Scale Rating of Device Satisfaction
Time frame: through study completion, an average of 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Layered Low Profile Foot and Prescribed Ankle in people with Amputation, run by Little Room Innovations, LLC 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 17 Sep 2025. 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 17 Sep 2025). 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?
Total Energy Stored (TES) (time frame: through study completion, an average of 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 17 Sep 2025.