Characterization of Residual Limb Volume Changes in Transfemoral Amputees (NCT04709367) | Clinical Trial Compass
CompletedNot Applicable
Characterization of Residual Limb Volume Changes in Transfemoral Amputees
Italy24 participantsStarted 2018-05-11
Plain-language summary
This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Residual limb volume changes
Timeframe: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
Trial details
NCT IDNCT04709367
SponsorIstituto Nazionale Assicurazione contro gli Infortuni sul Lavoro