BridgeMD
New treatment option for Prosthesis User
Official title Caesar Foot Take-Home Validation Testing
ClinicalTrials.gov ID: NCT07075198
What this study is testing
- What it's testing
- The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment. Participants will take the device home and use it throughout their daily life for two months.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have transtibial limb absence of one or both limbs
- Express interest in running, but do not currently have a running blade (as determined by self-report)
- Are at least 18 years of age
- Are at least six months post amputation
- Are classified as K3 or K4 ambulator status as determined by a certified prosthetist
You likely can't join if
- Present or sustained injuries to residual limb or contralateral leg affecting functional ability
- Non-English speaking participants will be excluded from this study due to limited access to interpreter services. These services would be needed for...
- Using a prosthetic foot that an individual is unfamiliar with for higher activity tasks may increase the risk of falling. Therefore, pregnant women...
See the full eligibility criteria
- Have transtibial limb absence of one or both limbs
- Express interest in running, but do not currently have a running blade (as determined by self-report)
- Are at least 18 years of age
- Are at least six months post amputation
- Are classified as K3 or K4 ambulator status as determined by a certified prosthetist
- Have an AMP score of at least 37
- Are capable of running safely as determined by a certified prosthetist's clinical judgement
- Have a well-fitting socket as determined by a certified prosthetist
- Have adequate clearance between distal end of the residual limb and ground for the Caesar foot
- Meets the foot size and weight class of one of the available Caesar prototypes
- Present or sustained injuries to residual limb or contralateral leg affecting functional ability
- Non-English speaking participants will be excluded from this study due to limited access to interpreter services. These services would be needed for several visits, including training to learn how to use the device...
- Using a prosthetic foot that an individual is unfamiliar with for higher activity tasks may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by...
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.