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NCT Number: NCT06923293

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 10MWT (Aim 1)

    Time frame: Measured before and after 6 week intervention to assess change from baseline.

    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.

  2. TUG (Aim 1)

    Time frame: Measured before and after 6 week intervention to assess change from baseline.

    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.

  3. 6MWT (Aim 1)

    Time frame: Measured before and after 6 week intervention to assess change from baseline.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Goworek

CONTACT

[email protected]

973-324-3560 ext. 3560

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Stevens Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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