BridgeMD
Tests treatment safety and results for Amputation
Official title Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis
ClinicalTrials.gov ID: NCT06214026
What this study is testing
- What it's testing
- People with lower extremity amputation (LEA) have persistent problems with balance, falls, residual limb pain, functional mobility, cognitive attention during gait, and satisfaction with participation in daily activities, despite using prostheses. The purpose of this randomized clinical trial is to advance understanding of how dynamic foot design features may help people with LEA This study will include people with above-knee amputations, or with bilateral amputations, or with below-knee amputations and lower levels of mobility.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Participants will be 16-years or older, regardless of gender, race, or ethnicity.
- Potential participants should reside in the community or an independent living environment.
- The upper weight limit is 165.6 kg (365 lbs.).
- Prosthetic foot sizes 22 cm (approximate US Men's shoe size 5) up to 30 cm (13 US Men's).
- Ability to walk more than 400 m on level ground without an increase in pain.
You likely can't join if
- Participants must not have conditions such as skin wounds that preclude the use of a prosthesis.
- People will be excluded if they have fluctuating conditions that may significantly alter gait mechanics during the \~10-week study. Examples include...
- Participants may use a walking aid but should not primarily rely on wheelchair mobility.
- People will be discontinued from the study if they become unable to use a prosthesis. Examples include major surgery and trauma. However, because of...
See the full eligibility criteria
- Participants will be 16-years or older, regardless of gender, race, or ethnicity.
- Potential participants should reside in the community or an independent living environment.
- The upper weight limit is 165.6 kg (365 lbs.).
- Prosthetic foot sizes 22 cm (approximate US Men's shoe size 5) up to 30 cm (13 US Men's).
- Ability to walk more than 400 m on level ground without an increase in pain.
- At least one year post-amputation and using a prosthesis
- People must have the ability to read, write, and comprehend English.
- Participants must not have conditions such as skin wounds that preclude the use of a prosthesis.
- People will be excluded if they have fluctuating conditions that may significantly alter gait mechanics during the \~10-week study. Examples include Parkinson's disease, alcoholism, brain tumor, and hereditary...
- Participants may use a walking aid but should not primarily rely on wheelchair mobility.
- People will be discontinued from the study if they become unable to use a prosthesis. Examples include major surgery and trauma. However, because of the potential for fluctuations in prosthesis use with this population...
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Mount Sterling, Ohio, United States
- Seattle, Washington, 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, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Mount Sterling, Ohio, United States; Seattle, Washington, 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.