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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT05601869
Eligibility Criteria:
Inclusion Criteria:
* US military Veterans that identify as women
* Transtibial (below-knee) amputation
* Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)
* Well fitting and well aligned prosthesis
* Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6
* Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection
Exclusion Criteria:
* Residual limb skin problems
* Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system
* Unable or unwilling to travel to Minneapolis
* Not a regular prosthesis user
* Mass over 125 kg
* Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
* Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT05601869
Study Brief:
Protocol Section:
NCT05601869