Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Injury
• Intervention / Treatment: Device: Utilization of motorized orthosis

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 novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance.

The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate Goworek; Phone Number: 3560 973-324-3560; Email: kgoworek@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Kate Chervin; Phone Number: 9733243560; Email: kgoworek@kesslerfoundation.org
      • Contact: Sharon Franco; Phone Number: 9733243521; Email: sfranco@kesslerfoundation.org
      • Principal Investigator: Karen J Nolan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults with lower limb injury; All enrolled subjects will be asked to complete the intervention.	Device: Utilization of motorized orthosis; While part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10MWT (Aim 1)	10 meter walk test to evaluate walking speed after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.	Measured before and after 6 week intervention to assess change from baseline.
TUG (Aim 1)	Timed up and go (TUG) test to measure functional balance and walking ability after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.	Measured before and after 6 week intervention to assess change from baseline.
6MWT (Aim 1)	6 minute walking test to evaluate endurance after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.	Measured before and after 6 week intervention to assess change from baseline.

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: Stevens Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries
• Other Study ID Numbers: D-1182-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No