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

NCT06923293 | Recruiting DMC

• 1 other identifier: D-1182-22
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Injury

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

Adults with lower limb injury

EXPERIMENTAL

All enrolled subjects will be asked to complete the intervention.

Device: Utilization of motorized orthosis

Interventions

Utilization of motorized orthosis DEVICE

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

Adults with lower limb injury

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• Stevens Institute of Technology: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Kate Goworek

CONTACT

973-324-3560; kgoworek@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate DIrector

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)