Characterization of Residual Limb Volume Changes in Transfemoral Amputees

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Status: Completed

Conditions: Amputation Stump

Treatments: Other: 3D optical scan

Study type: Observational

Funder types: Other

Identifiers

NCT04709367

P-PPRAI1/2-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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