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

NCT ID: NCT06923293

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-06-01

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 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.

Conditions

Lower Limb Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adults with lower limb injury

All enrolled subjects will be asked to complete the intervention.

Group Type: EXPERIMENTAL

Utilization of motorized orthosis

Intervention Type: DEVICE

While part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stevens Institute of Technology

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Karen J. Nolan, PhD

Associate DIrector

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kate Goworek

Role: CONTACT

kgoworek@kesslerfoundation.org

973-324-3560 ext. 3560

Facility Contacts

Kate Chervin

Role: primary

kgoworek@kesslerfoundation.org

9733243560

Sharon Franco

Role: backup

sfranco@kesslerfoundation.org

9733243521

Other Identifiers

D-1182-22

Identifier Type: -

Identifier Source: org_study_id