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:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT02864693
Eligibility Criteria:
Inclusion Criteria:
* Unilateral transtibial amputation
* Age 18-99 years old
* Body weight below 275 lbs
* Non-pregnant
* English speaking
* Current user of prosthesis for at least one year
* Wear time 8 hrs/day or more
* MFCL ≥ K-3
* Well-fitting and functioning prosthesis
* No use of ambulatory aide
* Able to tolerate testing protocol
* Able to walk on slopes
* Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments
Exclusion Criteria:
* Amputation level other than unilateral transtibial
* Age \<18 or \>99 years old
* Body weight above 275 lbs
* Pregnant
* Non-English speaking
* Not current user of prosthesis
* Less than one year use of prosthesis
* Wear time less than 8 hr/day
* MFCL \<K3
* Poor fitting and functioning prosthesis
* Indicating that the socket fit is painful, or unacceptable
* Use of ambulatory aide
* Unable to tolerate testing protocol
* Unable to walk on slopes
* Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study
* Any neurologic impairments known to cause gait and/or balance dysfunction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02864693
Study Brief:
Protocol Section:
NCT02864693