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Recruiting NCT06923293

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

No phase Interventional Lower Limb Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Utilization of motorized orthosis.
Who it may be relevant to
Registry conditions: Lower Limb Injury. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • 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.

Primary outcome measures

  • 10MWT (Aim 1) [Time frame: Measured before and after 6 week intervention to assess change from baseline.]
  • TUG (Aim 1) [Time frame: Measured before and after 6 week intervention to assess change from baseline.]
  • 6MWT (Aim 1) [Time frame: Measured before and after 6 week intervention to assess change from baseline.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Kessler Foundation — West Orange

Identifiers

NCT: NCT06923293 · D-1182-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗