Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis
Recruiting now · Not applicable
Conditions studied: Lower Limb Injury
In brief
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.
Key facts
- Study ID
- NCT06923293
- Run by
- Kessler Foundation
- People needed
- 19
- Starts
- 2025-06-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-08-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Kessler Foundation — West Orange, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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