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Completed

NCT Number: NCT04709367

Characterization of Residual Limb Volume Changes in Transfemoral Amputees

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

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Key information

Conditions

Amputation Stump

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

INAIL Prosthesis Centre

Bologna, BO, 40054, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D optical scan

Other

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.

Primary outcomes

  1. 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

  1. Pressure distribution at the prosthetic socket - residual limb interface

    Time frame: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks

    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).

Sponsors and collaborators

Lead sponsor

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Other

Collaborators

  • Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2021
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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