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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06874582
Enrollment
32
Registered
2025-03-13
Start date
2021-10-15
Completion date
2022-05-13
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEsilicone 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.

DEVICEsilicone 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.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Nottingham Health Profile (NHP)through study completion, an average of 1 yearThe 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.
Trinity Amputation and Prosthesis Experience Scales (TAPES)through study completion, an average of 1 yearThe 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.
Visual Analog Scale(VAS)through study completion, an average of 1 yearThe 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026