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New treatment option for Lower Limb Injury
Official title Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis
ClinicalTrials.gov ID: NCT06923293
What this study is testing
- What it's testing
- The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.
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 80
You may be able to join if
- Have a lower limb injury greater than a year ago.
- Be 18-80 years old.
- Be able to stand for 30 minutes.
- Have enough range of motion in my ankle to comfortably wear the AFO.
- Be able to follow directions and commands.
You likely can't join if
- Have any joint or muscle tightness that would limit my movement while walking with the AFO.
- Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
- Have any medical issues that affect my unaffected side.
- Have skin issues that would prevent wearing the device.
- Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate...
- Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
See the full eligibility criteria
- Have a lower limb injury greater than a year ago.
- Be 18-80 years old.
- Be able to stand for 30 minutes.
- Have enough range of motion in my ankle to comfortably wear the AFO.
- Be able to follow directions and commands.
- Be willing and able to give informed consent.
- Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.
- Have any joint or muscle tightness that would limit my movement while walking with the AFO.
- Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
- Have any medical issues that affect my unaffected side.
- Have skin issues that would prevent wearing the device.
- Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure).
- Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
- Have nervous system issues that affect my movement (for example Parkinson's disease, multiple sclerosis).
- Have additional orthopedic issues that interfere with my walking or limit my range of motion in my legs.
- Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the device.
The study team makes the final eligibility decision.
Where it's taking place
- West Orange, New Jersey, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Orange, New Jersey, 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.