Image

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

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

Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details
    Lower Limb Injury

NCT06923293

Kessler Foundation

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.