MedTrace Logo

Characterization of Residual Limb Volume Changes in Transfemoral Amputees

NCT04709367 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2021-01-14

No results posted yet for this study

Summary

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

Conditions

  • Amputation Stump

Interventions

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.

Sponsors & Collaborators

  • Scuola Superiore Sant'Anna di Pisa

    collaborator OTHER

  • Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

    lead OTHER

Principal Investigators

  • Emanuele Gruppioni · INAIL Prosthesis Centre

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-11
Primary Completion
2020-08-31
Completion
2020-09-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709367 on ClinicalTrials.gov