Comparison of Ischial Containment and Subischial Sockets Effect on Gait Biomechanics in People With Transfemoral Amputation: A Randomized Crossover Trial.

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.