BridgeMD
New treatment option for Amputation
Official title Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
ClinicalTrials.gov ID: NCT06830876
What this study is testing
- What it's testing
- The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss. Maintaining a healthy, pain-free residual limb is a primary concern for prosthesis users.
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 100. Healthy volunteers may be eligible.
You may be able to join if
- 18 years or older
- Have a unilateral transtibial amputation
- Have normal sound limb range of motion and function
- Have a minimum of 4" length limb from tibial tubercle to end of residuum to allow room for NMES pads
- Report current pain at a level 3 or higher on a Visual Analog Scale (VAS)
You likely can't join if
- Have used electrical stimulation on the residual limb in the past six months
- Have been diagnosed as a severe diabetic or self-report insensate skin
- Have the presence of open wounds/ulcers on the residual limb
- Have experienced a cerebrovascular accident (stroke) or nerve injury to a lower limb
- Wear a pacemaker or implanted cardiac defibrillator
See the full eligibility criteria
- 18 years or older
- Have a unilateral transtibial amputation
- Have normal sound limb range of motion and function
- Have a minimum of 4" length limb from tibial tubercle to end of residuum to allow room for NMES pads
- Report current pain at a level 3 or higher on a Visual Analog Scale (VAS)
- Pass a monofilament test on the residual limb in 7 out of 10 areas to ensure adequate sensation for NMES stimulation
- Have a body mass index (BMI) of 35 kg/cm2 or less as NMES works more effectively on lower BMI
- Have used electrical stimulation on the residual limb in the past six months
- Have been diagnosed as a severe diabetic or self-report insensate skin
- Have the presence of open wounds/ulcers on the residual limb
- Have experienced a cerebrovascular accident (stroke) or nerve injury to a lower limb
- Wear a pacemaker or implanted cardiac defibrillator
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, 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 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, 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.