Objective: To compare gait biomechanics of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket to the ischial containment (IC) socket.
Design: Randomized crossover trial with 2, 7-week periods.
Setting: Private prosthetic clinics and university research laboratory.
Participants: A total of 30 enrolled (n=30); 25 participants completed the study with full (n=18) or partial data (n=7).
Interventions: Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery.
Main outcome measures: Gait analyses were conducted at 1, 4, and 7 weeks post socket delivery. Differences between sockets in selected gait variables related to hip motion and coronal plane socket stability were assessed.
Results: For participants with data for both sockets at week 7 (n=19), there were no significant differences in any gait variables between sockets at self-selected normal walking speed. However, when all participants and all study time points were assessed (n=25), there was a significant main effect of socket (P=.013), with prosthetic side sagittal plane hip range of motion being significantly greater for the NU-FlexSIV Socket at self-selected normal walking speed. There were no other significant effects.
Conclusions: The results suggest that, compared to the IC socket, the NU-FlexSIV Socket did not alter gait biomechanics related to hip motion and coronal plane socket stability in people with unilateral transfemoral amputation.
Trial registration: ClinicalTrials.gov NCT02678247.
Keywords: Artificial limbs; Gait analysis; Leg; Rehabilitation; Treatment outcome.
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