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

NCT ID: NCT06874582

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-05-13

Brief Summary

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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.

Detailed Description

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Conditions

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Amputation Quality of Life Psychosocial Adaptation Silicone Prosthesis Functionality

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

silicone hand or finger prosthesis

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

silicone foot and foot toe prosthesis

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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ESRA ATILGAN

Assoc.Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Medipol University

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-10840098-772.02-5247

Identifier Type: -

Identifier Source: org_study_id

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