Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees

NCT06599060 | Completed DMC

• 1 other identifier: YaziciH
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Transtibial Amputation - Unilateral

Keywords

transtibial amputees; prosthesis satisfaction; prosthesis experience

Outcome Measures

Primary Outcomes (1)

• Trinity Amputation and Prosthetic Experience Scales (TAPES)

  It will be used to evaluate the prosthetic experience.

  0-1 years

Secondary Outcomes (1)

• Satisfaction with the Prosthesis (SATPRO) Questionnaire

  0-1 years

Interventions

Trinity Amputation and Prosthesis Experience Scale OTHER

Participants were administered a questionnaire.

Also known as: Satisfaction with Prosthesis Questionnaire

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Information on patients who had undergone unilateral transtibial prosthesis placement in previous years was obtained from the patient records of the Nesa Prosthetics Orthotics Production and Application Center.

You may qualify if:

• between 18-75
• unilateral below knee amputation
• volunteer to participate
• have been using a transtibial prosthesis for at least one year
• can read and understand Turkish.

You may not qualify if:

• muscle strength and sensory loss in the intact extremity that may affect ambulation
• upper limb amputees
• congenital amputees
• bilateral amputees
• mentally disabled
• with neurological disease

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol University

Beykoz, Istanbul, 34290, Turkey (Türkiye)

Location

Related Links

• Related Info

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: December 10, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)