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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT02328859
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be unilateral transtibial amputees (TTA) between the ages of 18 and 65 who have consistently used a prosthesis for at least one year.
* Subjects must be community ambulators at a K3 level,
* which dictates that they have the ability or potential to walk with variable cadence,
* to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.
Exclusion Criteria:
* History of surgical procedures on their intact limb.
* Subjects will be excluded from the study if they present with
* cardiovascular,
* neurological,
* or balance disorders that can affect gait.
* Rheumatoid arthritis,
* knee joint replacement,
* and the use of ambulatory aids will also exclude participation.
* Subjects with considerable pain in their knee joints, as measured by a visual analog scale will also be excluded due to the confounding effects of pain on gait patterns.
* A medical history screening will be used to identify subjects with pre-existing conditions that would compromise their gait.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02328859
Study Brief:
Protocol Section:
NCT02328859