Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial.

Abstract

BACKGROUND\nThere are alternative transfemoral (TF) socket interface designs that have not been compared with the standard of care, ischial ramus containment (IRC). The interface directly affects performance.\n\n\nOBJECTIVES\nTo compare 3 TF interface designs, IRC, dynamic socket (DS), and subischial (Sub-I), regarding gait, balance, mobility, and preference. The authors hypothesized that these more active users may experience gait, mobility, and preference benefits from the less intrusive DS and Sub-I interface designs.\n\n\nSTUDY DESIGN\nSingle-blind, repeated-measures, 3-period randomized controlled crossover clinical trial.\n\n\nMETHODS\nPeople with unilateral TF amputation with 1 year or longer prosthesis use experience, independent community ambulatory status, 18 to 60 years of age, of any race or ethnicity, with a body mass of 45 to 125 kg, and with a self-reported ability to walk for 20 minutes continuously were included in the study. Each participant was fit in all 3 interface designs.\n\n\nRESULTS\nThirteen participants completed the clinical trial. Velocity, cadence, mobility, and balance were not statistically different between the 3 socket conditions. The DS demonstrated significantly greater symmetry in swing, stance, single support percentage, and toe angle compared with IRC and Sub-I. Sixty days after study completion, 7 participants changed interfaces, trending away from IRC.\n\n\nCONCLUSIONS\nLarge differences were not observed. Small differences in spatiotemporal gait measures combined with patient preference may make a meaningful difference to individual patients and should be considered.