Reliability and Construct Validity of the Turkish Version of the Prosthesis Donning and Doffing Questionnaire in Transtibial Amputees.

Turkish Validation of Prosthesis Donning and Doffing Questionnaire

Sponsors

Lead sponsor: Marmara University

Source Marmara University
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.

Detailed Description

Knowing that a socket and suspension system should be donned and doffed few times during the day and night, it is important to measure ease of donning and doffing. Effortless donning and doffing does appear to have a posi- tive effect on satisfaction with a prosthesis. The socket and suspension systems require different methods of don and doff, some of which are time-consuming and necessi- tate more hand strength and cognitive effort than others. The pin/lock suspension needs few re-adjustments of residual limb within the socket so that the pin is fully locked distally. The seal-in system, for example, needs a longer period as first the amputee needs to spray either the inner socket or the seals, and then remove the socket valve and push the limb into the socket and put back the valve. Instruments are available to evaluate socket comfort such as the socket comfort score, yet to the authors' knowledge no instrument has been developed that focuses on donning and doffing quality of prosthesis. The clearer the insight into suspension systems, the easier will be the selection for prosthetist.

There are different questionnaires in the fields of prosthetics and orthotics such as Prosthetic Evaluation Questionnaire (PEQ), Trinity Amputation and Prosthesis Experience Scales (TAPES), Orthotic Prosthetic User's Survey (OPUS), Houghton scale of prosthetic use, and Amputee Body Image Scale (ABIS) However, few of these instruments address donning and doffing of prosthesis. There is no questionnaire in Turkish available to evaluate the donning and doffing procedures of suspension systems. Thus, 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.

After obtaining permission from the developers of the Prosthesis donning and doffing questionnaire, the Turkish version of the instrument will be developed. For the translation process, established guidelines for patient reported outcome (PRO) instrument translation and include both forward and backward (reverse) translation of instructions, items, and response options by independent translators; review by bilingual experts; reconciliation of translations; and cognitive testing of the translated instruments, as described by Eremenco et al., 2005 or Reeve et al., 2013 were followed.The necessity of performing a cultural adaptation for the use of the Turkish version among Turkish amputees will be assessed. Level of education part of the manuscript is planned to be changed bacause it doesn't fit the education system in Turkey). After discussions between the study investigators and translators, a Turkish version of the Prosthesis donning and doffing questionnaire that corresponded as closely as possible to the original survey will be produced. Each subject will be asked to complete the Turkish version of the Prosthesis donning and doffing questionnaire twice (1-3 days apart). To evaluate the validity of the Turkish version of the Prosthesis donning and doffing questionnaire, the Nottingham Health Profile(NHP), Satisfaction with Prosthesis -SATPRO surveys will be used.

Satisfaction with the prosthesis has the following subscales: aesthetic satisfaction with the prosthesis, weight satisfaction with the prosthesis and functional satisfaction with the prosthesis. The weight satisfaction subscale has just one item, which is answered with a 5-point Likert-type scale, whereas both aesthetic satisfaction and functional satisfaction with prosthesis have five items, each answeredwith a 5-point Likert-type scale.

The Turkish version of Nottingham Health Profile(NHP), a generic quality of life measurement tool, has been showed to be a valid and reliable outcome measurement. For this reason it will be used to analyse the construct validity of the Prosthesis donning and doffing questionnaire. NHP (translated by Küçükdeveci et a.) includes the following six subdomains: energy level, physical activities, pain, sleep, emotional reaction and social isolation. The sum of the scores of each subdomain equals.12 The SATPro is a 15-item questionnaire that measures general satisfaction with a prosthesis. The Turkish version of the questionnaire, developed by Simsek, was used. Each item on the questionnaire is scored between 0 and 3.

Overall Status Completed
Start Date December 1, 2017
Completion Date June 30, 2019
Primary Completion Date June 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Prosthesis donning and doffing questionnaire Day 0
Prosthesis donning and doffing questionnaire Day 3
Secondary Outcome
Measure Time Frame
Satisfaction with Prosthesis -SATPRO Day 0
Satisfaction with Prosthesis -SATPRO Day 3
Nottingham Health Profile Day 0
Nottingham Health Profile Day 3
Enrollment 30
Condition
Intervention

Intervention type: Other

Intervention name: Satisfaction with Prosthesis -SATPRO

Description: questionnaire 1

Arm group label: Test group: Transtibial amputees

Intervention type: Other

Intervention name: Nottingham Health Profile-NHP

Description: questionnaire 2

Arm group label: Test group: Transtibial amputees

Intervention type: Other

Intervention name: Prosthesis donning and doffing questionnaire

Description: questionnaire 3

Arm group label: Test group: Transtibial amputees

Eligibility

Sampling method: Probability Sample

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

1. Bilateral amputation or upper extremity amputation

2. Amputation levels other than transtibial

3. Cognitif impairement

4. Presence of neuroma, bony growths, skin lesions, wounds leading unability to use prosthesis.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Overall Official
Last Name Role Affiliation
Giray Esra, MD Study Director Marmara University
Location
facility
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Location Countries

Turkey

Verification Date

October 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Test group: Transtibial amputees

Description: 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).

Patient Data No
Study Design Info

Observational model: Other

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov