Limb Health and Socket Pressure in Response to Powered Ankle Protheses (NCT05112679) | Clinical Trial Compass
CompletedNot Applicable
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
United States6 participantsStarted 2021-11-15
Plain-language summary
this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 18 and above
* Weight ≤ 280 lb
* Ambulate at a K3 level or higher-level determined from patient EHR
* At least 3 months post-amputation per physician discretion
* Residual limb length greater than 4.5 inches
* Use of a passive prosthesis
* Unilateral transtibial amputees
* Must be able to ambulate without any assistive devices
* Subjects must be able to follow directions and give informed consent on their own
Exclusion Criteria:
* Conditions and/or co-morbidities that would prevent wearing a prosthetic socket, affect gait, or influence function of the contralateral limb
* Other amputees
* Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant in the near future
* Individuals diagnosed with renal failure
* Participants unwilling to wear a cloth face covering for the duration of each visit