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Turkish Validation of Prosthesis Donning and Doffing Questionnaire

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ClinicalTrials.gov Identifier: NCT03347682
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Amputation; Traumatic, Leg, Lower Other: Satisfaction with Prosthesis -SATPRO Other: Nottingham Health Profile-NHP Other: Prosthesis donning and doffing questionnaire

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Reliability and Construct Validity of the Turkish Version of the Prosthesis Donning and Doffing Questionnaire in Transtibial Amputees.
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Group/Cohort Intervention/treatment
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
questionnaire 1

Other: Nottingham Health Profile-NHP
questionnaire 2

Other: Prosthesis donning and doffing questionnaire
questionnaire 3




Primary Outcome Measures :
  1. Prosthesis donning and doffing questionnaire [ Time Frame: Day 0 ]
    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.

  2. Prosthesis donning and doffing questionnaire [ Time Frame: Day 3 ]
    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.


Secondary Outcome Measures :
  1. Satisfaction with Prosthesis -SATPRO [ Time Frame: Day 0 ]
    The questionnaire includes 15 items developed on the basis of the most significant criteria used by the person when selecting a technical aid. Minimum score 0 maximum score 45.

  2. Satisfaction with Prosthesis -SATPRO [ Time Frame: Day 3 ]
    The questionnaire includes 15 items developed on the basis of the most significant criteria used by the person when selecting a technical aid. Minimum score 0-maximum score 45.

  3. Nottingham Health Profile [ Time Frame: Day 0 ]
    The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. The number of questions answered "yes" in each subgroup is divided by the total number of questions in the same subgroup and the result is multiplied by 100. Each subgroup has a value of between 0 and 100, with 100 points being considered the best general QoL for the calculated subgroup and 0 points being considered as the worst QoL for the same subgroup.

  4. Nottingham Health Profile [ Time Frame: Day 3 ]
    The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. The number of questions answered "yes" in each subgroup is divided by the total number of questions in the same subgroup and the result is multiplied by 100. Each subgroup has a value of between 0 and 100, with 100 points being considered the best general QoL for the calculated subgroup and 0 points being considered as the worst QoL for the same subgroup.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Transtibial amputees aged 18-65 years and using their well fitted prosthesis at least 1 year
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347682


Contacts
Contact: Giray Esra, MD 2166570606 ext 1628 girayesra@hotmail.com
Contact: Osman Hakan Gündüz, Prof 2166570606 ext 1628 drhakangunduz@hotmail.com

Locations
Turkey
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Recruiting
İstanbul, Turkey, 34899
Contact: Esra Giray, MD    2166570606    girayesra@hotmail.com   
Principal Investigator: Osman Hakan Gündüz, Prof         
Sponsors and Collaborators
Marmara University
Investigators
Study Director: Giray Esra, MD Marmara University

Publications of Results:

Other Publications:
Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03347682     History of Changes
Other Study ID Numbers: 09.2017.659
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marmara University:
Amputation, prosthesis,psychometrics, questionnaires

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries