Clinical trial NCT04709367: Characterization of Residual Limb Volume Changes in Transfemoral Amputees
Official title: Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation Stump
Keywords: Amputee
Prosthetic socket
Transfemoral residual limb
Volume change
3D scan
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant'Anna di Pisa
First posted: 2021-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: transfemoral amputees

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.

Eligibility criteria: 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

Primary outcomes:
measure: Residual limb volume changes
timeFrame: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
Secondary outcomes:
measure: Pressure distribution at the prosthetic socket - residual limb interface
timeFrame: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: INAIL Prosthesis Centre
state: BO
Study officials:
affiliation: INAIL Prosthesis Centre
name: Emanuele Gruppioni
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.