Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT06599060
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees
Sponsor:
Medipol University
Organization:
Study Overview
Official Title:
Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees
Status:
COMPLETED
Status Verified Date:
2024-09
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:
None
Brief Summary:
This study aimed to investigate the experience and satisfaction of unilateral transtibial amputees with prostheses. This study included 31 unilateral transtibial amputees aged 18-75 years. The Prosthesis Satisfaction Questionnaire (PSQ) and Trinity Amputation and Prosthesis Experience Scale (TAPES) were used to measure prosthesis satisfaction. Data analyses were performed using SPSS for Windows version 24.0 program. No significant data were found when the SATPRO scale scores were compared with general information. The TAPES activity restriction scale scores were lower in women than in men (p\<0.05). When the causes of amputation were compared, the mean scores of the TAPES activity restriction, TAPES athletic restriction, and TAPES social restriction subscales were higher in amputees with vascular causes than in those with traumatic and other causes (p\<0.05). Satisfaction with TAPES prosthesis weight was lower in vascular amputees than in traumatic and other amputees (P \<0.05). The TAPES restriction compliance score was higher in the vascular amputee group than in the traumatic and other cause groups (p\<0.05). There was no difference in the TAPES and SATPRO scores according to the different types of prostheses used by the amputees (p\>0.05). Researchers believe that the cause of amputation and cosmetic limitations affect prosthesis satisfaction and are also important for prosthesis adaptation and socialization for users.
Detailed Description:
None
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?: