The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars: 1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase. 2. The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase. 3. An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot. The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
The subject will wear the PRO-FLEX PIVOT foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test
The subject will wear his usual Class III ESAR Foot foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test
Multiples locations
Multiple Locations, France
RECRUITINGChange of mobility of the patient
Assess the foot impact on the patient mobility assessed with Prosthetic Limb Users Survey of Mobility (PLUS-M™) questionnaire. The score ranges from 21.8 (indicated lower mobility) to 71.4 (indicating higher mobility)
Time frame: 28 days
Variations in comfort experienced during the wearing of the foot
Evaluate the impact of the foot on the comfort experienced by the patient with visual analog scale (VAS) from 0 (= not at all comfortable) to 5 (=Very comfortable)
Time frame: 28 days
Change in quality of life
Evaluate the impact of the foot on the quality of life assessed by the Orthotics Prosthetics Users Survey (OPUS) patient Self report questionnaire. The higher the score \[0-92\], the better the perception of quality of life.
Time frame: 28 days
Change in satisfaction of the patient
Assess the change in patient satisfaction with Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); Higher scores indicate greater satisfaction.
Time frame: 28 days
Occurence of falls
Time frame: 28 days
Number of patients with technical incidents
Time frame: 28 days
Noël MARTINET, PhD
CONTACT
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