BridgeMD
New treatment option for Transfemoral Amputation
Official title Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
ClinicalTrials.gov ID: NCT05831696
What this study is testing
- What it's testing
- The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
- a body mass greater than 49Kg and less than 117Kg
- 18-75 years of age
- Have an ambulation potential of K3 or K4
- Use a prosthesis daily for walking or sports activities
You likely can't join if
- Cannot walk at different speeds (MCFL K0-K2)
- Limb-loss below the knee or through the hip
- More than one amputation.
- Uses an assistive device for walking
- Uncontrolled edema in leg compartments
- Compromised skin of the residual limb or contralateral foot
See the full eligibility criteria
- Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
- a body mass greater than 49Kg and less than 117Kg
- 18-75 years of age
- Have an ambulation potential of K3 or K4
- Use a prosthesis daily for walking or sports activities
- No less than six months of experience with a prosthesis
- No socket issues or changes in the last six weeks
- No residual limb pain affecting functional ability.
- Cannot walk at different speeds (MCFL K0-K2)
- Limb-loss below the knee or through the hip
- More than one amputation.
- Uses an assistive device for walking
- Uncontrolled edema in leg compartments
- Compromised skin of the residual limb or contralateral foot
- Are 180 days or less post-amputation
- Pregnant (self-reported)
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, 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.