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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT02765035
Eligibility Criteria:
Inclusion Criteria:
* Person is \>18 years old.
* Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.
* Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL).
* Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months.
* Person was never fitted with microprocessor controlled prosthetic knee joint.
* Person is willing and able to independently provide informed consent.
* Person is willing to comply with study procedures.
* Person wears prosthesis daily and ≥ 8 hours/day.
* Person is walking on average 1km/day.
* Person is walking not slower than 3km/h (\~0.8m/s) (based on 10m walk test conducted during recruiting).
* Person is walking on level ground in a step over step manner.
Exclusion Criteria:
* Person is under 18 years of age.
* Person who weighs more than 136kg.
* Person who weighs less than 50kg.
* Person who is pregnant.
* Person has a history of chronic skin breakdown on the residual limb.
* Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking).
* Person falls ≥ once a week due to the reasons that could not be corrected by the new prosthesis (for ex. problems with vestibular system).
* Person is using under arm axillary crutches or walker.
* Person in an emergency, life threatening situation.
* Person is unwilling/unable to follow instructions.
* Person who is not available to follow the entire study protocol.
* Person who is participating in another study or intends to participate in another study during this study duration.
* Person who cannot personally provide their consent.
* Person who is not wearing prosthesis 8hours/day on average.
* Person who has a score on 10m walk test less than 3km/h (\~0.8m/s) (based on 10m walk test conducted during recruiting).
* Person who walks on average less than 1km per day.
* Person who is not able to walk on level ground in a step over step manner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02765035
Study Brief:
Protocol Section:
NCT02765035