Prosthetic Satisfaction, Body Image, and ICF Outcomes After Amputation

NCT07385859 | Completed DMC

• 1 other identifier: OMU2025/148
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Lower limb amputation affects not only physical mobility but also psychological well-being, body perception, and involvement in daily and social life. Although prosthetic use is essential for restoring mobility, rehabilitation outcomes may be influenced by multiple physical and psychosocial factors. Understanding the relationships between prosthetic satisfaction, body image, and activity and participation may contribute to improved rehabilitation planning after amputation. This observational, cross-sectional study aims to investigate the relationships between prosthetic satisfaction, body image, and activity and participation outcomes in adults with unilateral lower limb amputation who use a prosthesis. The study includes adults with unilateral transtibial amputation who have been using a prosthesis for daily activities. Participants complete standardized self-report questionnaires to assess prosthetic satisfaction using the Trinity Amputation and Prosthesis Experience Scales, body image perception using the Amputee Body Image Scale, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework. Activity outcomes focus on the ability to perform daily physical tasks such as standing, walking, stair negotiation, and mobility on different surfaces. Participation outcomes focus on involvement in daily routines, social interactions, transportation, work, and leisure activities. Statistical analyses are planned to examine the associations between prosthetic satisfaction, body image, and activity and participation outcomes, while considering demographic and prosthesis-related factors such as age and duration of prosthesis use.

Conditions

Lower Limb Amputation Below Knee; Body Image; Activities of Daily Living; ICF; Participation; Transtibial Amputation - Unilateral

Keywords

body image; Lower Limb Amputation; Activities of Daily Living; Social Participation; ICF

Outcome Measures

Primary Outcomes (4)

• ICF-Based Participation Score

  Participation was assessed using an ICF-based participation questionnaire consisting of 9 items related to involvement in daily routines and social life, including indoor and outdoor mobility, use of public transportation, self-care, helping others, interpersonal interactions, employment, and leisure activities. Each item was scored on a 5-point scale ranging from 0 (no difficulty) to 4 (complete difficulty). Lower scores indicate better participation.

  Baseline

• ICF-Based Activity Score

  Activity was assessed using an ICF-based activity questionnaire consisting of 8 items related to daily physical activities, including changing body position, standing, walking short and long distances, walking on different surfaces, negotiating obstacles, stair ambulation, and driving. Each item was scored on a 5-point scale ranging from 0 (no difficulty) to 4 (complete difficulty). Lower scores indicate better activity performance.

  Baseline

• Body Image (Amputee Body Image Scale, ABIS)

  Body image perception is evaluated using the Amputee Body Image Scale (ABIS), a 20-item self-report questionnaire designed to assess body image disturbance in individuals with limb amputation. Each item is rated on a 5-point Likert scale. Total scores range from 20 to 100, with higher scores indicating greater body image disturbance.

  Baseline

• Prosthetic Satisfaction (Trinity Amputation and Prosthesis Experience Scales, TAPES) - Description

  Prosthetic satisfaction is assessed using the Trinity Amputation and Prosthesis Experience Scales (TAPES). The prosthetic satisfaction domain evaluates satisfaction with prosthesis aesthetics, weight, and functional performance. Items are scored on a Likert scale, with total scores ranging from 3 to 15, and higher scores indicating greater prosthetic satisfaction.

  Baseline

Study Arms (1)

Adults with Unilateral Lower Limb Amputation

This cohort consisted of adults with unilateral transtibial lower limb amputation who had been using a prosthesis for at least one year. Participants were able to ambulate independently with a prosthesis and had no significant neurological or musculoskeletal conditions affecting mobility. No experimental intervention was applied as part of the study. All participants underwent a single-session assessment including self-report questionnaires evaluating prosthetic satisfaction, body image, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

No intervention was administered as part of this study. This was an observational, cross-sectional study in which participants received no experimental treatment, device, or behavioral intervention. Data were collected during a single assessment session using self-report questionnaires to evaluate prosthetic satisfaction, body image, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework.

Adults with Unilateral Lower Limb Amputation

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adults aged 18 to 64 years with unilateral transtibial lower limb amputation who had been using a prosthesis for at least one year. Participants were able to ambulate independently with a prosthesis and had no major neurological, musculoskeletal, cognitive, or psychiatric conditions affecting mobility or questionnaire completion. All participants were recruited from a single prosthetics and orthotics center and provided written informed consent prior to participation.

You may qualify if:

• Adults aged 18 to 64 years
• Unilateral transtibial lower limb amputation
• Use of a prosthesis for at least one year
• Ability to ambulate independently with a prosthesis
• Ability to read and understand questionnaires
• Voluntary participation with written informed consent

You may not qualify if:

• Congenital limb deficiency
• Bilateral lower limb amputation
• Neurological disorders affecting mobility (e.g., stroke, Parkinson's disease)
• Severe musculoskeletal conditions influencing gait or balance
• Recent prosthetic replacement within the previous six months
• Severe residual limb pain or uncontrolled phantom limb pain
• Cognitive or psychiatric impairment that could interfere with questionnaire completion

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55270, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mine PEKESEN KURTÇA P PEKESEN KURTÇA, PhD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 4, 2026
• Study Start: April 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)