Restoring Culturally Essential Floor-Sitting in Transfemoral Prosthesis Users: A Six-Week Pilot Randomized Within-Subject Trial
DOI:
https://doi.org/10.33192/smj.v78i10.283845Keywords:
transfemoral prosthesis, socket design, floor-sitting, quality of life, resource-limited settingAbstract
Objective: Floor-sitting, including cross-legged and side-sitting, is culturally essential in many Asian societies but is often prevented by conventional transfemoral sockets. The Asian Transfemoral Socket (ATS) is a low-profile, femoraladducted design that aims to restore floor-sitting through socket geometry rather than costly add-on components.
Materials and Methods: In a pilot randomized within-subject trial, 14 community walkers with unilateral transfemoral amputation were assessed with the ATS after six weeks of use and with their own socket, in randomized order. The primary outcome was floor-sitting attainment (cross-legged and side-sitting); secondary outcomes were socket comfort (SCS), prosthesis-related quality of life (PEQ), walking capacity (6MWT), dynamic balance (4SST), and daily step count. Outcomes were analyzed using Wilcoxon signed-rank and McNemar tests, with rank-biserial correlations as effect sizes.
Results: Cross-legged was attained by 12 participants with the ATS (p < 0.001) and side-sitting by 6 additional participants (p = 0.031). The ATS showed large effect sizes on comfort and quality of life, significant on two of four SCS ratings and two of three PEQ scales, whereas walking, balance, and activity did not differ (6MWT r = 0.09; 4SST r = 0.29; steps r = -0.05).
Conclusion: The ATS was associated with better floor-sitting and patient-reported outcomes. No statistically supported mobility difference was detected (paired median differences: 6MWT +0.4 m [95% CI -3.5 to 11.3], 4SST -0.21 s [-0.44 to 0.21], steps/day -23 [-449 to 521]); clinically important harm cannot be excluded. Cost, fabrication time, training, maintenance, and service delivery were not evaluated; findings are limited to this Thai center.
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