Characterization of Residual Limb Volume Changes in Transfemoral Amputees

Study Overview
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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.

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.

Official Title
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Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.

Conditions
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Amputation Stump

Intervention / Treatment
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* Other: 3D optical scan


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual limb volume changes | 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. | The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure distribution at the prosthetic socket - residual limb interface | Pressure distributions at the residual limb/ socket interface are measured by the F-Socket Pressure Measurement System, during: Walking (five gait cycles, three times); Walking up and down slope (five gait cycles, three times); Walking upstairs and downstairs (six stairs cycles, three times); Sitting down and up (three times). | The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputee, Prosthetic socket, Transfemoral residual limb, Volume change, 3D scan