Characterization of Residual Limb Volume Changes in Transfemoral Amputees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-11

Study Completion Date

2020-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Amputation Stump

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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3D optical scan

The clinical protocol consisted of four test sessions in four different days for an overall duration of 3 weeks. During the 1st session, amputees' residual limb volume was measured 7 times at intervals of 10 minutes after the prosthesis removal. During the subsequent sessions, the residual limb volume was measured immediately after the prosthesis doffing and after the amputee's stabilization time, before and after 15-min of walking on a treadmill, both in the morning and in the afternoon.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes