The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.
Department of Excellence in Robotics & AI, Scuola Superiore Sant'Anna, Pisa, Italy.
Sci Rep. 2021 Jun 10;11(1):12273. doi: 10.1038/s41598-021-91647-9.
This study constitutes the first attempt to systematically quantify residual limb volume fluctuations in transfemoral amputees. The study was carried out on 24 amputees to investigate variations due to prosthesis doffing, physical activity, and testing time. A proper experimental set-up was designed, including a 3D optical scanner to improve precision and acceptability by amputees. The first test session aimed at measuring residual limb volume at 7 time-points, with 10 min intervals, after prosthesis doffing. This allowed for evaluating the time required for volume stabilization after prosthesis removal, for each amputee. In subsequent sessions, 16 residual limb scans in a day for each amputee were captured to evaluate volume fluctuations due to prosthesis removal and physical activity, in two times per day (morning and afternoon). These measurements were repeated in three different days, a week apart from each other, for a total of 48 scans for each amputee. Volume fluctuations over time after prosthesis doffing showed a two-term decay exponential trend (R = 0.97), with the highest variation in the initial 10 min and an average stabilization time of 30 min. A statistically significant increase in residual limb volume following both prosthesis removal and physical activity was verified. No differences were observed between measures collected in the morning and in the afternoon.Clinical Trials.gov ID: NCT04709367.
本研究首次尝试系统地量化股骨截肢者残肢体积的波动。该研究在 24 名截肢者中进行,以研究由于假肢脱下、体力活动和测试时间引起的变化。设计了适当的实验装置,包括 3D 光学扫描仪,以提高精度和截肢者的可接受性。第一次测试旨在测量 7 个时间点的残肢体积,每个时间点之间间隔 10 分钟,在假肢脱下后。这使得每个截肢者都可以评估假肢移除后体积稳定所需的时间。在随后的会议中,每天对每个截肢者进行 16 次残肢扫描,以评估由于假肢移除和体力活动引起的体积波动,每天两次(上午和下午)。这些测量在三个不同的日子里重复进行,每个日子之间相隔一周,每个截肢者总共进行了 48 次扫描。在假肢脱下后随时间的体积波动显示出双项衰减指数趋势(R=0.97),在最初的 10 分钟内变化最大,平均稳定时间为 30 分钟。验证了假肢移除和体力活动后残肢体积的统计学显著增加。在上午和下午收集的测量值之间没有观察到差异。临床试验.gov ID:NCT04709367。