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 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT01225432
Eligibility Criteria:
Inclusion Criteria
* Unilateral traumatic trans-tibial or transfemoral amputation
* Independent ambulation without an assistive device for a minimum of three months
* Ability to ambulate continuously for a minimum of 15 minutes
* Trans-femoral participants must use an ischial containment socket
* VAS Pain scores on the involved side of less than 4/10
* Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.
Exclusion Criteria:
* Blindness
* TBI-Glascow Coma Scale score of 12 or lower at the time of injury
* Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01225432
Study Brief:
Protocol Section:
NCT01225432