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

Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods

This study will test whether a custom motorized ankle-foot brace helps adults with older lower limb injuries walk more comfortably, with less pain, and better gait after a six-week program.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Kessler Foundation (Academic / other)
• Locations: 1 site (West Orange, New Jersey)
• Trial ID: NCT06923293 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with a lower limb injury over one year old who can stand for 30 minutes, have sufficient ankle range of motion to wear an AFO, can follow directions, and can attend in-person sessions at the study site.

Not a fit: Patients with severe spasticity or joint/muscle contractures, unstable cardiovascular disease or recent cardiac hospitalization, significant skin issues, or other conditions that prevent safe weight-bearing or wearing the device are unlikely to benefit.

Why it matters

Potential benefit: If successful, patients could have less pain, greater walking comfort, improved gait mechanics, and increased confidence and independence during walking.

How similar studies have performed: Powered AFOs and robot-assisted gait training have shown promise for improving gait and comfort in prior work, but machine-learning driven self-adaptive AFO designs remain largely experimental.

Eligibility criteria

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 this trial is running

West Orange, New Jersey

• Kessler Foundation — West Orange, New Jersey, United States (Recruiting)

Study contacts

• Study coordinator: Kate Goworek

Conditions Lower Limb Injury