Characterization of Residual Limb Volume Changes in Transfemoral Amputees

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

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

Study Overview

• Status: Completed
• Conditions: Amputation Stump
• Intervention / Treatment: Other: 3D optical scan

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40054
      • INAIL Prosthesis Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

transfemoral amputees

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual limb volume changes	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.	The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure distribution at the prosthetic socket - residual limb interface	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).	The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks

Collaborators and Investigators

• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
• Collaborators: Scuola Superiore Sant'Anna di Pisa
• Investigators: Principal Investigator: Emanuele Gruppioni, INAIL Prosthesis Centre

Publications and helpful links

General Publications

• Paterno L, Ibrahimi M, Rosini E, Menfi G, Monaco V, Gruppioni E, Ricotti L, Menciassi A. Residual limb volume fluctuations in transfemoral amputees. Sci Rep. 2021 Jun 10;11(1):12273. doi: 10.1038/s41598-021-91647-9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2018
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Amputee; Prosthetic socket; Transfemoral residual limb; Volume change; 3D scan
• Other Study ID Numbers: P-PPRAI1/2-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No