Ignite Creation Date:
2025-12-18 @ 8:11 AM
Ignite Modification Date:
2025-12-18 @ 8:11 AM
Study NCT ID:
NCT07159724
Status:
None
Last Update Posted:
2025-09-08 00:00:00
First Post:
2025-08-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Turkish Version of the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE): Reliability and Validity
Sponsor:
None
Organization:
Study Overview
Official Title:
Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) in Individuals With Back and Neck Pain
Status:
None
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be carried out at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Spine Health Unit. Individuals who apply to the rehabilitation program and use biomedical devices will be included. Inclusion criteria are: presence of back or neck pain for at least three months, use of a supportive biomedical device in the rehabilitation program, literacy, age between 18-65 years, and voluntary participation with written informed consent. Exclusion criteria include malignancy, pregnancy, neurological or systemic disease causing functional loss, surgery within the last six months, acute infection, unhealed fracture, or withdrawal of consent at any stage.
The cross-cultural adaptation of the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire will be conducted according to established guidelines. Permission has been obtained from the original author. Two bilingual translators (a physiotherapist with a PhD and a linguist from Hacettepe University School of Foreign Languages) will independently translate the questionnaire into Turkish. Their translations will be reviewed by an expert committee consisting of three health professionals and three linguists. Back-translation into English will be performed by two native English speakers. Following review and consensus, a pre-final Turkish version will be created. The pre-test phase will include 10 individuals with back or neck pain who used biomedical devices in rehabilitation. Comprehensibility, clarity, and time to complete the questionnaire will be evaluated. Items that are unclear will be revised or removed.
A total of 150-300 participants will be recruited, following the recommendation of 5-10 participants per item for validation studies. Data collection will include demographic information (age, sex, weight, height, occupation, education, diagnosis), the Turkish USE Questionnaire, Neck Disability Index, Oswestry Disability Index, Quebec User Evaluation of Satisfaction with Assistive Technology, and Numeric Pain Rating Scale. Device-related usefulness, learning, and ease of use will be evaluated using Visual Analog Scales. The USE Questionnaire will be administered twice, with a three-day interval, to assess test-retest reliability.
Statistical analyses will be performed using IBM SPSS. Construct validity will be examined using factor analysis and correlations with established scales. Internal consistency will be assessed by Cronbach's alpha coefficient, and test-retest reliability will be evaluated using intraclass correlation coefficients. These methodological steps will ensure the scientific rigor, validity, and reliability of the Turkish version of the USE Questionnaire. The adapted instrument is expected to provide a standardized and reliable tool to evaluate usability of biomedical devices and technologies in physiotherapy and rehabilitation settings, filling an important gap in the Turkish literature.
The cross-cultural adaptation of the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire will be conducted according to established guidelines. Permission has been obtained from the original author. Two bilingual translators (a physiotherapist with a PhD and a linguist from Hacettepe University School of Foreign Languages) will independently translate the questionnaire into Turkish. Their translations will be reviewed by an expert committee consisting of three health professionals and three linguists. Back-translation into English will be performed by two native English speakers. Following review and consensus, a pre-final Turkish version will be created. The pre-test phase will include 10 individuals with back or neck pain who used biomedical devices in rehabilitation. Comprehensibility, clarity, and time to complete the questionnaire will be evaluated. Items that are unclear will be revised or removed.
A total of 150-300 participants will be recruited, following the recommendation of 5-10 participants per item for validation studies. Data collection will include demographic information (age, sex, weight, height, occupation, education, diagnosis), the Turkish USE Questionnaire, Neck Disability Index, Oswestry Disability Index, Quebec User Evaluation of Satisfaction with Assistive Technology, and Numeric Pain Rating Scale. Device-related usefulness, learning, and ease of use will be evaluated using Visual Analog Scales. The USE Questionnaire will be administered twice, with a three-day interval, to assess test-retest reliability.
Statistical analyses will be performed using IBM SPSS. Construct validity will be examined using factor analysis and correlations with established scales. Internal consistency will be assessed by Cronbach's alpha coefficient, and test-retest reliability will be evaluated using intraclass correlation coefficients. These methodological steps will ensure the scientific rigor, validity, and reliability of the Turkish version of the USE Questionnaire. The adapted instrument is expected to provide a standardized and reliable tool to evaluate usability of biomedical devices and technologies in physiotherapy and rehabilitation settings, filling an important gap in the Turkish literature.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: