Actively Recruiting
Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods in Adults With Lower Limb Injury
Led by Kessler Foundation · Updated on 2025-08-26
19
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kessler Foundation
Lead Sponsor
S
Stevens Institute of Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults who have experienced a lower limb injury to evaluate the comfort, convenience, and effectiveness of walking using a motor-powered ankle foot orthosis (AFO) brace. The study aims to improve rehabilitation outcomes through a new adaptive AFO design that uses machine learning to provide personalized assistance. The goal is to enhance gait mechanics and reduce pain compared to daily-use AFOs, encouraging active participation in rehabilitation. Participants will be fitted with a custom motorized AFO and will complete walking tests both with and without the device. The intervention lasts for six weeks and focuses on robot-assisted gait training using this innovative, self-adaptive orthosis. All enrolled subjects will complete the intervention as part of the study. During the study, participants will undergo walking assessments before and after the six-week period, including the 10-meter walk test, timed up and go test, and six-minute walk test to measure improvements in walking ability. Researchers will monitor comfort, pain, and gait changes throughout. Participants must be able to stand and follow directions, and they will be followed for the duration of the intervention to evaluate their progress.
CONDITIONS
Brief Title
Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Have any joint or muscle tightness that would limit movement while walking with the AFO.
- Have any medical issue preventing weight support and walking, such as orthopedic injuries, pain, or severe spasticity.
- Have medical issues affecting the unaffected side.
- Have skin issues preventing device wear.
- Have pre-existing conditions causing exercise intolerance, including 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 before enrollment.
- Have nervous system disorders affecting movement, like Parkinson's disease or multiple sclerosis.
- Have additional orthopedic issues limiting walking or ankle range of motion.
- Have other medical conditions your doctor or physical therapist believes may affect device use.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants are fitted for the custom motorized orthosis and complete walking tests with and without the device to assess gait improvements.
Multiple visits during the 6-week rehabilitation program
Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
K
Kate Goworek
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here