Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Residual limb volume changes
研究概览
简要总结
This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.
详细描述
The first test session aims at measuring residual limb volume at 7 time-points, with 10 minute intervals, after prosthesis doffing. This allows 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 are captured to evaluate volume changes due to prosthesis removal and physical activity, in two times per day (one in the morning, one in the afternoon). These measurements are repeated in three different days, a week apart from each other, for a total of 48 scans for each amputee.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stabilized (i.e., time since amputation > 18 months) transfemoral amputees
- •Age between 18 and 65 years old
- •Subjects able to safely perform the physical tasks required in the experimental protocol
- •Subjects provided with prostheses
排除标准
- •Denial of informed consent to participate in the study
- •Inability to maintain the required position during the 3D scanning for at least 5 minutes
- •Concomitant general or localized comorbidities / disabilities, which may interfere with the study
- •Pathological conditions affecting the residual limb
- •Allergy / sensitivity with polydimethylsiloxane (PDMS)
- •Pathological cardiopulmonary / cardiovascular conditions
- •Pregnancy or breastfeeding
- •Presence of psychiatric co-morbidities
- •Presence of cognitive deficits which may compromise the understanding of the required tasks
- •Difficulty in understanding the Italian language
- •Insufficient degree of collaboration
- •Consumption of alcohol or diuretics before tests
结局指标
主要结局
Residual limb volume changes
时间窗: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
Residual limb volume changes due to prosthesis doffing, physical activity, and testing time are measured by a proper experimental set-up, including a 3D metrology-grade optical scanner.
次要结局
- Pressure distribution at the prosthetic socket - residual limb interface(The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks)