Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amputation Stump
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Residual limb volume changes
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Residual limb volume changes
Time Frame: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
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.
Secondary Outcomes
- Pressure distribution at the prosthetic socket - residual limb interface(The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks)