Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot (NCT04239222) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
United States27 participantsStarted 2020-03-10
Plain-language summary
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Person is 18 years or older.
✓. Currently uses an energy storage and return foot.
✓. Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
✓. For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
✓. Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm
✓. Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL).
✓. Prosthetic foot size is 24 to 27 centimeters.
✓. Socket Comfort Score of at least 7
Exclusion criteria
✕. Current prosthetic foot is too old or worn out as assessed by the CPO.
✕. TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
✕. Patient is pregnant or planning to become pregnant.
✕. Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
✕. Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking, problems with vestibular system, etc.).
What they're measuring
1
Patient-perceived Mobility (PLUS-M)â„¢
Timeframe: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot