Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT05456295
Eligibility Criteria:
PARTICIPANTS WITH PTOA:
Inclusion Criteria:
1. Ages 18-65.
2. Diagnosis of ankle PTOA.
3. Ability to walk 50 feet at a slow to moderate pace.
4. Ability to walk without a cane or crutch.
5. Ability to read and write in English and provide written informed consent.
Exclusion Criteria:
1. Diagnosis with a moderate or severe brain injury.
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition…).
3. Ankle weakness as a result of spinal cord injury or nervous system pathology.
4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity.
5. Rheumatoid or inflammatory arthritis.
6. Necrosis of any bones in the foot or ankle.
7. Pain of 8/10 or greater during walking.
8. Surgery on study limb anticipated in the next 6 months.
9. Uncorrected visual or hearing impairments.
10. Require use of a stabilizing device (i.e. Ankle Foot Orthosis or Knee Orthosis…) to perform daily activities.
11. Pregnancy
12. Body mass index greater than 40.
HEALTHY ABLE-BODIED PARTICIPANTS:
Inclusion Criteria:
1. Ages 18-65.
2. Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
3. Ability to hop without pain.
4. Ability to perform a full squat without pain.
5. Ability to read and write in English and provide written informed consent.
Exclusion Criteria:
1. Diagnosis with a moderate or severe brain injury.
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition).
3. Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
4. Medical conditions of injuries limiting function for greater than 6 weeks.
5. Uncorrected visual or hearing impairments.
6. Use of an assistive device.
7. Pregnancy
8. Body mass index greater than 35.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05456295
Study Brief:
Protocol Section:
NCT05456295