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Completed

NCT Number: NCT06599060

Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medipol University

Beykoz, Istanbul, 34290, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Trinity Amputation and Prosthesis Experience Scale

Other

Participants were administered a questionnaire.

Other names: Satisfaction with Prosthesis Questionnaire

Primary outcomes

  1. Trinity Amputation and Prosthetic Experience Scales (TAPES)

    Time frame: 0-1 years

    It will be used to evaluate the prosthetic experience.

Secondary outcomes

  1. Satisfaction with the Prosthesis (SATPRO) Questionnaire

    Time frame: 0-1 years

    It will be used to assess denture satisfaction.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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