Prosthetic Satisfaction, Body Image, and ICF Outcomes After Amputation

Ondokuz Mayıs University

Status: Completed

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

Treatments: Other: No intervention (observational study)

Study type: Observational

Funder types: Other

Identifiers

NCT07385859

OMU2025/148

Details and patient eligibility

About

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.

Full description

This observational, cross-sectional study is conducted within the framework of the International Classification of Functioning, Disability and Health (ICF) to explore psychosocial and functional aspects of rehabilitation after unilateral lower limb amputation. The study focuses on understanding how prosthetic-related and person-related factors jointly relate to activity performance and participation in daily life.

Participants are adults with unilateral transtibial amputation who have been using a prosthesis in daily life. The study adopts a biopsychosocial perspective, emphasizing that rehabilitation outcomes after amputation are not determined solely by physical capacity or prosthetic characteristics but also by psychological factors such as body image and subjective satisfaction with the prosthesis.

Prosthetic satisfaction is evaluated as a multidimensional construct reflecting comfort, functionality, and personal acceptance of the prosthesis, while body image is considered a key psychosocial factor influencing movement confidence, self-perception, and engagement in daily and social activities. Activity and participation are examined as distinct but related domains in accordance with the ICF conceptual model.

By examining the relationships between prosthetic satisfaction, body image, and ICF-based activity and participation outcomes, this study aims to contribute to a more comprehensive understanding of rehabilitation after lower limb amputation. The findings are expected to support patient-centered rehabilitation planning by highlighting psychosocial targets alongside prosthetic and functional considerations.

Enrollment: 27 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

27 participants in 1 patient group

Adults with Unilateral Lower Limb Amputation

Description:

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.

Treatment:

Other: No intervention (observational study)