NCT06923293 Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis
| NCT ID | NCT06923293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | Lower Limb Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 19 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 19 participants in total. It began in 2025-06-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06923293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lower Limb Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06923293 currently recruiting?
Yes, NCT06923293 is actively recruiting participants. Contact the research team at kgoworek@kesslerfoundation.org for enrollment information.
Where is the NCT06923293 trial being conducted?
This trial is being conducted at West Orange, United States.
Who is sponsoring the NCT06923293 clinical trial?
NCT06923293 is sponsored by Kessler Foundation. The trial plans to enroll 19 participants.