NCT04709367

Characterization of Residual Limb Volume Changes in Transfemoral Amputees

Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.

Detailed description

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.

Conditions

• Amputation Stump

Interventions

Type	Name	Description
OTHER	3D optical scan	The clinical protocol consisted of four test sessions in four different days for an overall duration of 3 weeks. During the 1st session, amputees' residual limb volume was measured 7 times at intervals of 10 minutes after the prosthesis removal. During the subsequent sessions, the residual limb volume was measured immediately after the prosthesis doffing and after the amputee's stabilization time, before and after 15-min of walking on a treadmill, both in the morning and in the afternoon.

Timeline

• Start date: 2018-05-11
• Primary completion: 2020-08-31
• Completion: 2020-09-30
• First posted: 2021-01-14
• Last updated: 2021-01-14

Locations

1 site across 1 country: Italy