NCT04709367

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

January 12, 2021

Last Update Submit

January 12, 2021

Conditions

Amputation Stump

Keywords

AmputeeProsthetic socketTransfemoral residual limbVolume change3D scan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

3D optical scanOTHER

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

transfemoral amputees

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INAIL Prosthesis Centre

Bologna, BO, 40054, Italy

Location

Related Publications (2)

  • Paterno L, Truppa L, Ibrahimi M, Rosini E, Gruppioni E, Ricotti L, Menciassi A. Quantitative analysis of interface pressures in transfemoral prosthetic sockets. Prosthet Orthot Int. 2024 Apr 1;48(2):176-183. doi: 10.1097/PXR.0000000000000251. Epub 2023 Jun 28.

    PMID: 37379468DERIVED

  • Paterno L, Ibrahimi M, Rosini E, Menfi G, Monaco V, Gruppioni E, Ricotti L, Menciassi A. Residual limb volume fluctuations in transfemoral amputees. Sci Rep. 2021 Jun 10;11(1):12273. doi: 10.1038/s41598-021-91647-9.

    PMID: 34112873DERIVED

Study Officials

  • Emanuele Gruppioni

    INAIL Prosthesis Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

May 11, 2018

Primary Completion

August 31, 2020

Study Completion

September 30, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Locations

IT(1)