Helping adults walk better after a lower limb injury with a custom motorized ankle-foot brace

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site interventional project fits adults who had lower limb injuries more than one year ago with a motorized ankle-foot orthosis (AFO) that uses adaptive assistance and machine learning to individualize support. Participants will use the device during a six-week rehabilitation program with robot-assisted gait training and comparisons will be made to their usual daily-use AFOs. Outcomes include patient-reported comfort and pain, objective gait mechanics, and measures of engagement and self-efficacy. The protocol involves baseline and follow-up gait assessments, device tuning, and repeated in-person sessions at the study site.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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.

Where it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Kate Goworek
• Email: kgoworek@kesslerfoundation.org
• Phone: 973-324-3560

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.