Turkish Validation of Prosthesis Donning and Doffing Questionnaire

NCT03347682 | Completed

• 1 other identifier: 09.2017.659
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the Reliability and construct validity of the Turkish version of the Prosthesis donning and doffing questionnaire in transtibial amputees.

Conditions

Amputation; Traumatic, Leg, Lower

Keywords

Amputation, prosthesis,psychometrics, questionnaires

Outcome Measures

Primary Outcomes (2)

• Prosthesis donning and doffing questionnaire

  Satisfaction was measured through Prosthesis donning and doffing questionnaire. The total score may be categorized into "low, moderate, and high" as follows-total score ⩽ 2: low; total score = 3 and 4: moderate; and total score ⩾ 5: high. The higher score may be interpreted as higher quality and satisfaction with the donning and doffing.

  Day 0

• Prosthesis donning and doffing questionnaire

  Satisfaction was measured through Prosthesis donning and doffing questionnaire. The total score may be categorized into "low, moderate, and high" as follows-total score ⩽ 2: low; total score = 3 and 4: moderate; and total score ⩾ 5: high. The higher score may be interpreted as higher quality and satisfaction with the donning and doffing.

  Day 3

Secondary Outcomes (4)

• Satisfaction with Prosthesis -SATPRO

  Day 0

• Satisfaction with Prosthesis -SATPRO

  Day 3

• Nottingham Health Profile

  Day 0

• Nottingham Health Profile

  Day 3

Study Arms (1)

Test group: Transtibial amputees

After translation/retranslation of the Prosthesis donning and doffing questionnaire, transtibial amputees will be asked to complete a quality of life evaluation Nottingham Health Profile-NHP, a satisfaction evaluation Satisfaction with Prosthesis -SATPRO and the Turkish version of the Prosthesis donning and doffing questionnaire twice (1-3 days apart).

Other: Satisfaction with Prosthesis -SATPRO; Other: Nottingham Health Profile-NHP; Other: Prosthesis donning and doffing questionnaire

Interventions

Satisfaction with Prosthesis -SATPRO OTHER

questionnaire 1

Test group: Transtibial amputees

Nottingham Health Profile-NHP OTHER

questionnaire 2

Test group: Transtibial amputees

Prosthesis donning and doffing questionnaire OTHER

questionnaire 3

Test group: Transtibial amputees

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Transtibial amputees aged 18-65 years and using their well fitted prosthesis at least 1 year

You may qualify if:

• Transtibial amputee, who used prosthesis for at least 1 year and had no cognitive disorders.

You may not qualify if:

• Bilateral amputation or upper extremity amputation
• Amputation levels other than transtibial
• Cognitif impairement
• Presence of neuroma, bony growths, skin lesions, wounds leading unability to use prosthesis.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (7)

• Zhang M, Turner-Smith AR, Tanner A, Roberts VC. Clinical investigation of the pressure and shear stress on the trans-tibial stump with a prosthesis. Med Eng Phys. 1998 Apr;20(3):188-98. doi: 10.1016/s1350-4533(98)00013-7.

  PMID: 9690489 BACKGROUND

• Abu Osman NA, Eshraghi A, Gholizadeh H, Wan Abas WAB, Lechler K. Prosthesis donning and doffing questionnaire: Development and validation. Prosthet Orthot Int. 2017 Dec;41(6):571-578. doi: 10.1177/0309364617690397. Epub 2017 Feb 13.

  PMID: 28190376 RESULT

• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

  PMID: 15804318 RESULT

• Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.

  PMID: 10826123 RESULT

• Kuru P, Akyuz G, Yagci I, Giray E. Hypovitaminosis D in widespread pain: its effect on pain perception, quality of life and nerve conduction studies. Rheumatol Int. 2015 Feb;35(2):315-22. doi: 10.1007/s00296-014-3099-7. Epub 2014 Aug 2.

  PMID: 25085713 RESULT

• Schaffalitzky E, Gallagher P, Maclachlan M, Wegener ST. Developing consensus on important factors associated with lower limb prosthetic prescription and use. Disabil Rehabil. 2012;34(24):2085-94. doi: 10.3109/09638288.2012.671885. Epub 2012 Apr 12.

  PMID: 22494367 RESULT

• Eshraghi A, Osman NA, Gholizadeh H, Karimi M, Ali S. Pistoning assessment in lower limb prosthetic sockets. Prosthet Orthot Int. 2012 Mar;36(1):15-24. doi: 10.1177/0309364611431625. Epub 2012 Jan 22.

  PMID: 22269941 RESULT

Study Officials

• Giray Esra, MD

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: December 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 2, 2019

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)