RecruitingNot ApplicableNCT06923293
Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis
Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods
Sponsor
Kessler Foundation
Enrollment
19 participants
Start Date
Jun 1, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria7
- 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 Criteria9
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICEUtilization 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06923293