Characterization of Residual Limb Volume Changes in Transfemoral Amputees

Completed

• Conditions: Amputation Stump

• Registration Number: NCT04709367
• Lead Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Brief 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.

Study Timeline

• Study Start: 2018-05-11
• Primary Completion: 2020-08-31
• Study Completion: 2020-09-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Residual limb volume changes	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.

Secondary Outcome Measures

Name	Time	Method
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	Pressure distributions at the residual limb/ socket interface are measured by the F-Socket Pressure Measurement System, during: * Walking (five gait cycles, three times); * Walking up and down slope (five gait cycles, three times); * Walking upstairs and downstairs (six stairs cycles, three times); * Sitting down and up (three times).

Trial Locations

Locations (1)

INAIL Prosthesis Centre; 🇮🇹 Bologna, BO, Italy