Characterization of Residual Limb Volume Changes in Transfemoral Amputees

Amputation Stump Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709367
• Other study ID #: P-PPRAI1/2-01
• Status: Completed
• Start date: May 11, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2021
• Source: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation Stump

Intervention

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.

Locations

Country	Name	City	State
Italy	INAIL Prosthesis Centre	Bologna	BO

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro	Scuola Superiore Sant'Anna di Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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