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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT06284733
Eligibility Criteria:
Inclusion Criteria:
* 40 to 55 years of age.
* Residual femoral length from ischial tuberosity to the end of the limb with distal soft tissue compressed (15-35 cm)
* Unilateral trans-femoral traumatic amputation with single-axis mechanical knees, axial foot (single axis).
* Able to walk without the use of any assistive device; subjects must have obtained a score of \> 5 for Houghton Scale to indicate active use of prosthesis and \> 41 for Berg Balance Scale (BBS).
* Medicare level 3 (community) ambulatory or above.
* Ability to descend stairs and hills without caregiver and assistive devices.
* Be able to independently provide informed consent.
* Be willing to comply with study procedures.
Exclusion Criteria:
* Reduced somatosensory sensibility of the non-affected limb, ulceration or pain at the stump
* the amputation was of vascular origin
* Poor fittings of prosthesis
* Visual or vestibular impairment (vertigo or dizziness)
* Lower limb musculoskeletal injury and other neurological deficits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT06284733
Study Brief:
Protocol Section:
NCT06284733