Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees

September 16, 2024 updated by: Hande YAZICI, Medipol University
This study aimed to investigate the experience and satisfaction of unilateral transtibial amputees with prostheses. This study included 31 unilateral transtibial amputees aged 18-75 years. The Prosthesis Satisfaction Questionnaire (PSQ) and Trinity Amputation and Prosthesis Experience Scale (TAPES) were used to measure prosthesis satisfaction. Data analyses were performed using SPSS for Windows version 24.0 program. No significant data were found when the SATPRO scale scores were compared with general information. The TAPES activity restriction scale scores were lower in women than in men (p<0.05). When the causes of amputation were compared, the mean scores of the TAPES activity restriction, TAPES athletic restriction, and TAPES social restriction subscales were higher in amputees with vascular causes than in those with traumatic and other causes (p<0.05). Satisfaction with TAPES prosthesis weight was lower in vascular amputees than in traumatic and other amputees (P <0.05). The TAPES restriction compliance score was higher in the vascular amputee group than in the traumatic and other cause groups (p<0.05). There was no difference in the TAPES and SATPRO scores according to the different types of prostheses used by the amputees (p>0.05). Researchers believe that the cause of amputation and cosmetic limitations affect prosthesis satisfaction and are also important for prosthesis adaptation and socialization for users.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Beykoz, Istanbul, Turkey, 34290
        • Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Information on patients who had undergone unilateral transtibial prosthesis placement in previous years was obtained from the patient records of the Nesa Prosthetics Orthotics Production and Application Center.

Description

Inclusion Criteria:

  • between 18-75
  • unilateral below knee amputation
  • volunteer to participate
  • have been using a transtibial prosthesis for at least one year
  • can read and understand Turkish.

Exclusion Criteria:

  • muscle strength and sensory loss in the intact extremity that may affect ambulation
  • upper limb amputees
  • congenital amputees
  • bilateral amputees
  • mentally disabled
  • with neurological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trinity Amputation and Prosthetic Experience Scales (TAPES)
Time Frame: 0-1 years
It will be used to evaluate the prosthetic experience.
0-1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the Prosthesis (SATPRO) Questionnaire
Time Frame: 0-1 years
It will be used to assess denture satisfaction.
0-1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2020

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

May 15, 2021

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YaziciH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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