Evaluation of Individuals with Partial or Finger Amputation After Silicone Prosthesis Use

March 7, 2025 updated by: ESRA ATILGAN, Medipol University

EVALUATION of QUALITY of LIFE, PSYCHOSOCIAL ADAPTATION, and FUNCTIONALITY in SILICONE PROSTHESIS USERS

Objective: This study aimed to evaluate the psychosocial adaptation, functional capacity, and quality of life of individuals who underwent partial hand or foot amputations after using silicone hand and foot prostheses.

Materials and Methods: The study included 32 patients. Demographic and clinical characteristics of the participants were recorded. Participants were divided into two groups as silicone hand or foot prosthesis users. The Visual Analog Scale (VAS) was used to assess pain levels before and after prosthesis use, the Trinity Amputation and Prosthesis Experience Scales (TAPES) were applied to evaluate functional capacity, and the Nottingham Health Profile (NHP) was used to assess quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

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, Turkey
        • Istanbul 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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hand and foot amputation.
  • Aged between 18 and 60 years
  • Active employee
  • Able to walk, co-operate, move actively with hands
  • Who have been using prosthesis for at least 1 year and have good stump-socket compatibility,
  • Literate individuals were determined on a voluntary basis.

Exclusion Criteria:

  • Multiple amputations
  • Severe neurological or traumatic findings
  • Individuals with severe deformity or posture disorder that may lead to loss of gait, balance or function.
  • With limitation of movement in the upper extremities

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: silicone hand or finger prosthesis users
The first arm of our study consisted of participants with partial or finger amputation and silicone hand-finger prosthesis.
Device: silicone hand or finger prosthesis
To the best of the author's knowledge, no previous studies have evaluated and compared customised finger and partial silicone prostheses in both extremities. This feature distinguishes the present study from other studies.
Active Comparator: silicone foot or toe prostheses users
The second arm of our study consisted of participants with partial or finger amputation and silicone foot-foot toe prosthesis.
Device: silicone foot and foot toe prosthesis
To the best of the author's knowledge, no previous studies have evaluated and compared customised finger and partial silicone prostheses in both extremities. This feature distinguishes the present study from other studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nottingham Health Profile (NHP)
Time Frame: through study completion, an average of 1 year
The NHP questionnaire consists of two sections with "Yes-No" responses. The first section includes dimensions such as energy levels, pain, emotional reactions, sleep, social isolation, and physical abilities, while the second section addresses the impact of poor health on daily life, covering areas such as employment, household activities, social life, relationships, sexual life, hobbies, and vacations. The first section's total score ranges from 0-600, with higher scores indicating lower activity. The second section ranges from 0-7, with higher scores indicating lower activity.
through study completion, an average of 1 year
Trinity Amputation and Prosthesis Experience Scales (TAPES)
Time Frame: through study completion, an average of 1 year
The TAPES questionnaire evaluates psychosocial adaptation, functionality, and prosthesis satisfaction. It comprises two main sections with nine subscales. The psychosocial subscales include general adaptation, social adaptation, and restriction adaptation, with each rated on a five-point scale (1: Strongly Disagree to 5: Strongly Agree). Scores range from 5 to 25, with higher scores indicating better adaptation.
through study completion, an average of 1 year
Visual Analog Scale(VAS)
Time Frame: through study completion, an average of 1 year
The VAS was used to measure pain in the stump before and after silicone prosthesis use. They were asked to draw their pain level on a 10 cm scale between 0-10 points as 0=no pain, 10 unbearable pain
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Medipol University

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)

October 15, 2021

Primary Completion (Actual)

April 12, 2022

Study Completion (Actual)

May 13, 2022

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • E-10840098-772.02-5247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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