Status:
RECRUITING
Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis
Lead Sponsor:
Kessler Foundation
Collaborating Sponsors:
Stevens Institute of Technology
Conditions:
Lower Limb Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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.
Detailed Description
The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using no...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06923293
Start Date
June 1 2025
End Date
June 1 2027
Last Update
August 26 2025
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052