Amputation of Lower LimbNCT06648798
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
A study testing Limber Limb in people with Amputation of Lower Limb and Prosthesis, run by LIMBER Prosthetics & Orthotics Inc at 2 sites in United States.
Trial summary
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amputation of Lower Limb, Prosthesis, Non-inferiority Trial of Prothesis
- What is being tested?
- Limber Limb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2023to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Persons, aged 18 to 75
- In good general health as determined by clinical site monitor
- Weight < 125kg
- Are not diabetic (self reported)
Show all 11Show fewer
- Be a unilateral transtibial amputee of more than 1 year since amputation
- Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
- Live in the Southern California region (within 50 miles of UCSD)
- Has sufficient sensation in residual limb as tested by the clinical site monitor
- Agreement to adhere to Lifestyle Considerations throughout study duration 11a. Use the testing device (EPD or UniLeg) only during the testing periods. 11b. Walk at least 14,000 steps per week (average of 1 mile per day). 11c. Maintain a similar diet and activity level throughout study duration (no abrupt changes of weight, activity, etc.)
Who cannot join
- Not currently using a prosthetic device
- Prosthetic device with active motors, sensors, etc.
- Pregnancy (due to fall risk)
- Diabetic (due to poor limb sensation), self reported
- No under 18 (due to inability to consent)
- No over 75 (due to fall risk)
- Poor proprioception or sensation at the residual limb
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92093
David R Wing, MS, 858-534-9315, dwing@health.ucsd.edu
Michael Higgins, MS, 8585349315, mdhiggins@health.ucsd.edu
- Recruiting
Limber Prosthetics & Orthotics Inc
San Diego, California, 92111
Luca De Vivo, PhD, 310-602-9091, luca@limberprosthetics.com
Herb Barrack, CPO, (310) 602-9091, herb@limberprosthetics.com
About this study
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
Read the detailed description
Globally, 35-40 million people need prosthetics or other assistive devices, and this number is expected to double by 2050 due to factors including an aging population and the rise in diabetes. However, only 5-15% of people in need have access to prosthetics or other assistive devices, in both underserved and developed countries. The result is that millions of people are denied basic quality of life because they can't walk, take care of themselves, or participate in society. The lack of availability stems from several factors including poor access to clinics and high cost. Prosthetic devices are hand-sculpted and assembled by prosthetists via complex and time-consuming processes. High-cost 3rd party components are used to connect and align the hand-crafted components, leading to an expensive end-product.
Currently, several companies are successfully delivering 3D printed prosthetic sockets, but no one can deliver a fully 3D printed, single piece 'unibody' prosthesis. 3D printed sockets have been shown to provide increased comfort and fit and streamline the manufacturing process, but using traditional pylon, ankle/foot, and connector components lead to many of the same issues as traditional devices. Only 3D printing the socket may improve the outcome for people who could have gotten a traditional device but leaves behind the people in need who don't have access in the first place.
The custom-fit requirements make it difficult to mass-produce affordable devices and a lack of access to proper health care and medical professionals prevents adjustments needed to maintain safe, comfortable, and reliable prosthetic devices. This is critically important during the early recovery period when residual limbs change in shape due to atrophy and scar tissue formation, as well as having nerve endings that may be extra- sensitive. For children who grow quickly and need new devices every few months or years, swift access is both physically and psychologically important. Small imperfections at the prosthesis-limb interface can cause severe discomfort and may be the difference between an amputee wearing their prosthesis or choosing to forgo mobility. To obtain a well-fitted socket, prosthetists take measurements of the residual limb with a fitted liner and then mark anatomical areas on the limb. After assessing the limb, the prosthetist will use plaster bandages to create a cast around the limb. The anatomical marks will transfer to the interior of the mold, such that the prosthetist can attempt to design the socket to consider regions of bone or soft tissue. The prosthetist can manipulate the plaster bandages while they are hardening to adjust its shape. This shaping requires years of experience and will only result in a comfortable, functional socket if the prosthetist is highly skilled. Due to the expensive and time-consuming nature of this traditional process, new solutions are urgently needed.
Clinical Trial Justification:
During this study the study team expects to gather both quantitative and qualitative data that will be used to produce a performance report on the functionality of the LIMBER UniLeg. The goal of this trial is to provide evidence of non-inferiority of the intervention compared to the functional performance of similarly featured passive prosthetic devices, e.g. the patient's existing device.
This clinical trial will quantify the functionality, clinical efficacy, and quality of care of the LIMBER UniLeg and compare it to traditional passive prosthetic devices, referred to as existing prosthetic devices (EPD). This will provide evidence that LIMBER's novel 3D printing, scanning, and digital design workflow produces devices that are not inferior to traditionally manufactured prosthetic limbs.
- Being tested
- Limber Limb
- Keywords
- Prosthesis, Trans-tibial amputation, Limber Unileg, 3D Printed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limber LimbDevice
Participants will be involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month). Receives: Device: Limber Limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility - 6min walk
Measure total distance for a timed six-min walk test for both the Limber UniLeg vs. existing prosthetic devices.
Measured: Baseline, 4weeks, 8 weeks
Mobility - Timed-Up-and-Go
Measure time for the timed up and go (TUG) test for both the Limber UniLeg vs. existing prosthetic devices.
Measured: Baseline, 4weeks, 8 weeks
Mobility--25 foot walk
Time to cover 25 feet walking at a normal speed
Measured: All visits (Baseline, 4 weeks, 8 weeks)
Secondary outcomes (6)
Quality of Care - Gait Symmetry
Measure load distribution and stride length using a six-foot force pad test for both the UniLeg and existing prosthetic device to quantify gait symmetry.
Measured: Baseline, 4weeks, 8 weeks
Quality of Care - Perceived Balance Confidence_Limits of Stability
Assess Participant's Limit of Stability using the NeuroCom Balance Manager. Metrics include movement velocity, directional control, and maximal excursion in 8 directions (cardinal and semi-cardinal). Higher scores are better and indicative of both a wider cone of stability (associated with less fall risk) and balance confidence (associated with greater overall movement and less fall rsik)
Measured: Baseline, 4weeks, 8 weeks
Quality of Care - Perceived Balance Confidence_Adaptation Test
Assess Participant's Adaptation using the NeuroCom Balance Manager. Metrics include recovery time following a pertubation. Unit of measurement is milliseconds with higher scores being indicative of slower recovery (associated with higher fall risk). Across 5 trials participants are expected to improve.
The degree of improvement (Score 1-Score 5) is also a metric of interest with higher scores associated with less fall risk.
Measured: Baseline, 4weeks, 8 weeks
Quality of Care - Perceived Balance Confidence_Motor Control
Assess Participant's Motor Control using the NeuroCom Balance Manager. Metrics include stability following a pertubation. Unit of measurement is milliseconds with higher scores being indicative of slower recovery (associated with higher fall risk). Scores are averaged across multiple moderate and large pertubations in both the forward and backward directions.
Measured: Baseline, 4weeks, 8 weeks
Quality of Care - Utilization--At-home movement
Measure total steps measured for two weeks per assessment period using an Actigraph accelerometer. This will quantify utilization/daily ambulation while wearing the device(s), which will directly relate to patient satisfaction and comfort.
Measured: Baseline-4weeks, 4weeks-8weeks
Quality of Care - Utilization--Physical Activity Intensity
Measure daily minutes spent in sedentary, light moderate, and intense levels of physical activity for two weeks per assessment period using an Actigraph accelerometer. This will quantify intensity of activity while wearing the device(s) which will directly relate to patient satisfaction and comfort, and effect on daily activity which may have impacts on other health metrics.
Data will be derived based on movement levels using multiple potential cutpoints to quantify each minute as being one of the four potential activity bins. These are then summed across a day for activity level. Sleep time is removed by asking participants not to wear the device while in bed.
Measured: Baseline-4weeks, 4weeks-8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start20 Dec 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Amputation of Lower LimbStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LIMBER Prosthetics & Orthotics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Herb Barrack, CPO, Principal investigator, LIMBER Prosthetics & Orthotics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648798
- Sponsor's protocol ID
- 803632
- Other IDs
- 1R43HD112285-01A1
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Demographic and baseline outcomes will be presented using summary statistics. No individual data will be provided.
Publications
Holm, S. A simple sequentially rejective multiple test procedure. Scandinavian journal of statistics, 6(2):65-70, 1979.
Efron, B. and Tibshirani, R.J. An Introduction to the Bootstrap, Springer, New York, NY, 1993.
US Department of Health and Human Services C for DC and P. Assessment Timed Up and Go (TUG).; 2017. Accessed June 12, 2018
Sions JM, Beisheim EH, Manal TJ, Smith SC, Horne JR, Sarlo FB. Differences in Physical Performance Measures Among Patients With Unilateral Lower-Limb Amputations Classified as Functional Level K3 Versus K4. Arch Phys Med Rehabil. 2018 Jul;99(7):1333-1341. doi: 10.1016/j.apmr.2017.12.033. Epub 2018 Feb 1.
PubMed 29410114Reid L, Thomson P, Besemann M, Dudek N. Going places: Does the two-minute walk test predict the six-minute walk test in lower extremity amputees? J Rehabil Med. 2015 Mar;47(3):256-61. doi: 10.2340/16501977-1916.
PubMed 25588644Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14. doi: 10.1016/j.apmr.2006.10.015.
PubMed 17207685McCaffrey M, Beebe A. Managing your patients' adverse reactions to narcotics. Nursing. 1989 Oct;19(10):166-8. No abstract available.
PubMed 2586868Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
PubMed 16000093Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Heil DP, Brage S, Rothney MP. Modeling physical activity outcomes from wearable monitors. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S50-60. doi: 10.1249/MSS.0b013e3182399dcc.
PubMed 22157775Bassett DR Jr, Rowlands A, Trost SG. Calibration and validation of wearable monitors. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S32-8. doi: 10.1249/MSS.0b013e3182399cf7.
PubMed 22157772Freedson P, Bowles HR, Troiano R, Haskell W. Assessment of physical activity using wearable monitors: recommendations for monitor calibration and use in the field. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S1-4. doi: 10.1249/MSS.0b013e3182399b7e.
PubMed 22157769Rostagno C, Gensini GF. Six minute walk test: a simple and useful test to evaluate functional capacity in patients with heart failure. Intern Emerg Med. 2008 Sep;3(3):205-12. doi: 10.1007/s11739-008-0130-6. Epub 2008 Feb 26.
PubMed 18299800Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256.
PubMed 11157613Bartels B, de Groot JF, Terwee CB. The six-minute walk test in chronic pediatric conditions: a systematic review of measurement properties. Phys Ther. 2013 Apr;93(4):529-41. doi: 10.2522/ptj.20120210. Epub 2012 Nov 15.
PubMed 23162042
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
- ClinicalTrials.gov ID
- NCT06648798
- Acronym / sponsor ID
- 803632
- Keywords
- Prosthesis, Trans-tibial amputation, Limber Unileg, 3D Printed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LIMBER Prosthetics & Orthotics IncIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Oct 2024 (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 LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
Detailed description
Globally, 35-40 million people need prosthetics or other assistive devices, and this number is expected to double by 2050 due to factors including an aging population and the rise in diabetes. However, only 5-15% of people in need have access to prosthetics or other assistive devices, in both underserved and developed countries. The result is that millions of people are denied basic quality of life because they can't walk, take care of themselves, or participate in society. The lack of availability stems from several factors including poor access to clinics and high cost. Prosthetic devices are hand-sculpted and assembled by prosthetists via complex and time-consuming processes. High-cost 3rd party components are used to connect and align the hand-crafted components, leading to an expensive end-product.
Currently, several companies are successfully delivering 3D printed prosthetic sockets, but no one can deliver a fully 3D printed, single piece 'unibody' prosthesis. 3D printed sockets have been shown to provide increased comfort and fit and streamline the manufacturing process, but using traditional pylon, ankle/foot, and connector components lead to many of the same issues as traditional devices. Only 3D printing the socket may improve the outcome for people who could have gotten a traditional device but leaves behind the people in need who don't have access in the first place.
The custom-fit requirements make it difficult to mass-produce affordable devices and a lack of access to proper health care and medical professionals prevents adjustments needed to maintain safe, comfortable, and reliable prosthetic devices. This is critically important during the early recovery period when residual limbs change in shape due to atrophy and scar tissue formation, as well as having nerve endings that may be extra- sensitive. For children who grow quickly and need new devices every few months or years, swift access is both physically and psychologically important. Small imperfections at the prosthesis-limb interface can cause severe discomfort and may be the difference between an amputee wearing their prosthesis or choosing to forgo mobility. To obtain a well-fitted socket, prosthetists take measurements of the residual limb with a fitted liner and then mark anatomical areas on the limb. After assessing the limb, the prosthetist will use plaster bandages to create a cast around the limb. The anatomical marks will transfer to the interior of the mold, such that the prosthetist can attempt to design the socket to consider regions of bone or soft tissue. The prosthetist can manipulate the plaster bandages while they are hardening to adjust its shape. This shaping requires years of experience and will only result in a comfortable, functional socket if the prosthetist is highly skilled. Due to the expensive and time-consuming nature of this traditional process, new solutions are urgently needed.
Clinical Trial Justification:
During this study the study team expects to gather both quantitative and qualitative data that will be used to produce a performance report on the functionality of the LIMBER UniLeg. The goal of this trial is to provide evidence of non-inferiority of the intervention compared to the functional performance of similarly featured passive prosthetic devices, e.g. the patient's existing device.
This clinical trial will quantify the functionality, clinical efficacy, and quality of care of the LIMBER UniLeg and compare it to traditional passive prosthetic devices, referred to as existing prosthetic devices (EPD). This will provide evidence that LIMBER's novel 3D printing, scanning, and digital design workflow produces devices that are not inferior to traditionally manufactured prosthetic limbs.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Limber LimbParticipants will be involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Persons, aged 18 to 75
- In good general health as determined by clinical site monitor
- Weight < 125kg
Key exclusion criteria (7 listed)
- Not currently using a prosthetic device
- Prosthetic device with active motors, sensors, etc.
- Pregnancy (due to fall risk)
- Diabetic (due to poor limb sensation), self reported
- No under 18 (due to inability to consent)
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 |
|---|---|---|
| Limber LimbParticipants will be involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month). | Device | Intervention |
Primary outcome
Mobility - 6min walk
Time frame: Baseline, 4weeks, 8 weeks
Measure total distance for a timed six-min walk test for both the Limber UniLeg vs. existing prosthetic devices.
Mobility - Timed-Up-and-Go
Time frame: Baseline, 4weeks, 8 weeks
Measure time for the timed up and go (TUG) test for both the Limber UniLeg vs. existing prosthetic devices.
Mobility--25 foot walk
Time frame: All visits (Baseline, 4 weeks, 8 weeks)
Time to cover 25 feet walking at a normal speed
6 secondary outcomes
Quality of Care - Gait Symmetry
Time frame: Baseline, 4weeks, 8 weeks
Quality of Care - Perceived Balance Confidence_Limits of Stability
Time frame: Baseline, 4weeks, 8 weeks
Quality of Care - Perceived Balance Confidence_Adaptation Test
Time frame: Baseline, 4weeks, 8 weeks
Quality of Care - Perceived Balance Confidence_Motor Control
Time frame: Baseline, 4weeks, 8 weeks
Quality of Care - Utilization--At-home movement
Time frame: Baseline-4weeks, 4weeks-8weeks
Quality of Care - Utilization--Physical Activity Intensity
Time frame: Baseline-4weeks, 4weeks-8weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- BackgroundHolm, S. A simple sequentially rejective multiple test procedure. Scandinavian journal of statistics, 6(2):65-70, 1979.
- BackgroundEfron, B. and Tibshirani, R.J. An Introduction to the Bootstrap, Springer, New York, NY, 1993.
- BackgroundUS Department of Health and Human Services C for DC and P. Assessment Timed Up and Go (TUG).; 2017. Accessed June 12, 2018
- Background: PubMed 29410114Sions JM, Beisheim EH, Manal TJ, Smith SC, Horne JR, Sarlo FB. Differences in Physical Performance Measures Among Patients With Unilateral Lower-Limb Amputations Classified as Functional Level K3 Versus K4. Arch Phys Med Rehabil. 2018 Jul;99(7):1333-1341. doi: 10.1016/j.apmr.2017.12.033. Epub 2018 Feb 1.
- Background: PubMed 25588644Reid L, Thomson P, Besemann M, Dudek N. Going places: Does the two-minute walk test predict the six-minute walk test in lower extremity amputees? J Rehabil Med. 2015 Mar;47(3):256-61. doi: 10.2340/16501977-1916.
- Background: PubMed 17207685Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14. doi: 10.1016/j.apmr.2006.10.015.
- Background: PubMed 2586868McCaffrey M, Beebe A. Managing your patients' adverse reactions to narcotics. Nursing. 1989 Oct;19(10):166-8. No abstract available.
- Background: PubMed 16000093Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 22157775Heil DP, Brage S, Rothney MP. Modeling physical activity outcomes from wearable monitors. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S50-60. doi: 10.1249/MSS.0b013e3182399dcc.
- Background: PubMed 22157772Bassett DR Jr, Rowlands A, Trost SG. Calibration and validation of wearable monitors. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S32-8. doi: 10.1249/MSS.0b013e3182399cf7.
- Background: PubMed 22157769Freedson P, Bowles HR, Troiano R, Haskell W. Assessment of physical activity using wearable monitors: recommendations for monitor calibration and use in the field. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S1-4. doi: 10.1249/MSS.0b013e3182399b7e.
- Limber Prosthetics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Demographic and baseline outcomes will be presented using summary statistics. No individual data will be provided.
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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.
Herb Barrack, CPO principal investigator
LIMBER Prosthetics & Orthotics Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limber Limb in people with Amputation of Lower Limb and Prosthesis, run by LIMBER Prosthetics & Orthotics Inc at 2 sites 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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Wing, MS (8585349315, dwing@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility - 6min walk (time frame: Baseline, 4weeks, 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06648798, which also lists 20 linked publications.
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 26 Nov 2024.