Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:47 PM
Study NCT ID:
NCT07385859
Status:
COMPLETED
Last Update Posted:
2026-02-04
First Post:
2026-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prosthetic Satisfaction, Body Image, and ICF Outcomes After Amputation
Sponsor:
Ondokuz Mayıs University
Organization:
Study Overview
Official Title:
Prosthetic Satisfaction, Body Image, and Activity-Participation After Unilateral Lower Limb Amputation: An ICF-Based Analysis
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICF
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: