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Completed

NCT Number: NCT06874582

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

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.

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Key information

Conditions

Amputation Functionality Psychosocial Adaptation Quality of Life Silicone Prosthesis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

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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