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

NCT06874582 | Completed

• 1 other identifier: E-10840098-772.02-5247
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation; Quality of Life; Psychosocial Adaptation; Silicone Prosthesis; Functionality

Outcome Measures

Primary Outcomes (3)

• Nottingham Health Profile (NHP)

  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)

  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)

  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

Study Arms (2)

silicone hand or finger prosthesis users

ACTIVE COMPARATOR

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

silicone foot or toe prostheses users

ACTIVE COMPARATOR

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

Interventions

silicone hand or finger prosthesis 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 hand or finger prosthesis users

silicone foot and foot toe prosthesis 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Dr.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 13, 2025
• Study Start: October 15, 2021
• Primary Completion: April 12, 2022
• Study Completion: May 13, 2022
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

TU (1)