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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT03670004
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for the recruitment of subjects with below knee amputation include:
* Transtibial amputation
* Daily use of their clinically-prescribed prosthesis for ambulation without an assistive device
* Classified as Medicare Functional Classification Level K2- defined as a patient who "has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces - a typical community ambulator"
* Experience walking with a prosthesis for at least one year
* Residuum and amputated side in good condition (e.g., no adherent scars, lesions, ulcers, infections)
* Normal or corrected vision
* Able to walk a 10 m distance and stand quietly for 40 seconds without undue fatigue or health risk
Inclusion criteria for the recruitment of able-bodied controls include:
* Normal or corrected vision
* Able to walk a 10 m distance and stand quietly for 40 seconds without undue fatigue or health risk
* Suffered one or no falls in the previous 12 months
Exclusion Criteria:
Exclusion criteria for all recruited subjects (i.e., limb loss and control) include:
* Musculoskeletal (apart from amputation in the case of amputee subjects) and/or vestibular pathologies that would affect balance and/or stability
* Currently on medication that might affect proprioception and/or balance (e.g., drugs that are ototoxic, such as certain Aminoglycosides and pain killers)
* Cognitive deficits that preclude understanding of the instructions required to conduct the test
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT03670004
Study Brief:
Protocol Section:
NCT03670004