Status:
COMPLETED
Characterization of Residual Limb Volume Changes in Transfemoral Amputees
Lead Sponsor:
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Collaborating Sponsors:
Scuola Superiore Sant'Anna di Pisa
Conditions:
Amputation Stump
Eligibility:
All Genders
18-65 years
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 stabilizatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04709367
Start Date
May 11 2018
End Date
September 30 2020
Last Update
January 14 2021
Active Locations (1)
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1
INAIL Prosthesis Centre
Bologna, BO, Italy, 40054