NCT07159724

Brief Summary

In recent years, numerous technological products and devices have been developed in rehabilitation through advances in biomedical technology. These innovations support traditional rehabilitation services, offering more effective treatment methods and improving patients' adherence and participation. Increased compliance in treatment positively influences functional status, quality of life, and satisfaction. However, the diversity of biomedical products and the varying strength of their scientific foundations make it critical to evaluate them in terms of benefit, patient compliance, and usability. In physiotherapy and rehabilitation, objective tools for this purpose remain limited, which hinders accurate assessment of product effectiveness and the identification of improvements. Uncertainty regarding usability and ease of use may also result in inefficient utilization of resources. Questionnaires provide cost-effective tools to capture users' opinions, reflecting strengths and weaknesses of a product without the need for measurement devices. The Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire, developed by Arnold Lund in 2001, is a comprehensive 30-item scale scored on a 7-point Likert system. It evaluates usefulness, ease of use, ease of learning, and satisfaction, with items applicable across different products and services such as software, hardware, applications, or user support materials. Its multidimensional structure allows for the evaluation of usability in physiotherapy and rehabilitation technologies as well as in broader fields including robotics, social networking sites, diagnostic tools, and virtual reality. Despite its wide use internationally, no validated Turkish version of the USE Questionnaire exists. Establishing a culturally adapted, valid, and reliable Turkish version will address this gap and provide clinicians and researchers with a standardized tool for usability assessment. The aim of this study is to investigate the validity and reliability of the Turkish version of the USE Questionnaire.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 26, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

6 days

First QC Date

August 25, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

Musculoskeletal Painvalidaitonmedical deviceevaluation

Outcome Measures

Primary Outcomes (4)

  • Neck Disability Index

    It was developed by Vernon and colleagues as a neck version of the Oswestry Back Pain Scale. The Turkish version was developed by Aslan and colleagues. The Neck Disability Questionnaire consists of a total of 10 questions related to pain, personal care, concentration, work, driving, and sleeping. Each question is scored on a scale of 0 to 5. The total score is evaluated out of 50.

    Baseline (Day 1)

  • Usefulness, Satisfaction, and Ease of Use Questionnaire

    Developed by Arnold Lund in 2001, the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) is a comprehensive tool consisting of 30 items that assess various dimensions of usability. The questionnaire is scored on a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree") and includes a "None" option.

    Baseline (Day 1) and 3 days after initial assessment

  • Oswestry Disability Index

    Developed by Fairbank et al. to assess the level of functional loss in individuals with back pain. The Turkish version was developed by Yakut et al. The scale consists of 10 questions related to pain intensity, self-care, lifting and carrying, walking, sitting, standing, sleeping, degree of pain change, travel, and social life. Each question is scored on a scale of 0 to 5. The total score is evaluated out of 100.

    Baseline (Day 1)

  • Quebec Assistive Technology User Satisfaction Survey

    The Quebec Assistive Technology User Satisfaction Evaluation (Q-YTKMD) Questionnaire is a standardized questionnaire widely used to assess the satisfaction of individuals who use various assistive devices. The Q-YTKMD Questionnaire contains 12 items that inquire about satisfaction with assistive devices (8 items) and services (4 items). The validity and reliability of the Turkish version of the Q-YTKMD Survey have been established.

    Baseline (Day 1)

Secondary Outcomes (4)

  • Evaluation of the Benefit Level of Biomedical Devices

    Baseline (Day 1)

  • Assessment of the Ease of Learning Biomedical Devices

    Baseline (Day 1)

  • Evaluation of the Ease of Use of Biomedical Devices

    Baseline (Day 1)

  • Pain Severity Assessment

    Baseline (Day 1)

Study Arms (1)

People with low back and neck pain

Participants will be adults aged 18-65 years who have experienced low back or neck pain for at least 3 months and have undergone rehabilitation including at least one biomedical device (e.g., Back Up, Mollii Suit, Compex, or TENS). Eligible individuals must be literate and willing to provide informed consent. Exclusion criteria include malignancy, pregnancy, neurological or systemic disease causing functional loss, recent surgery within the last 6 months, acute infection, unhealed fracture, or withdrawal of consent.

Device: back up, mollii-suit, compex, tens

Interventions

In order to be included in this study, individuals must have undergone at least one session of treatment with a biomedical device. In the validity and reliability study of the Turkish version of the questionnaire, permission was first obtained from the questionnaire's author via e-mail. The Usefulness, Satisfaction and Ease of Use Questionnaire (USE) was translated from English into Turkish by two independent translators: one was a physiotherapist with a doctoral degree, and the other a faculty member at Hacettepe University School of Foreign Languages. Both translators were native Turkish speakers, fluent in English, and had no personal or professional interaction with each other. They evaluated the original questionnaire in terms of meaning and grammar to produce the Turkish version of the Usefulness, Satisfaction and Ease of Use Questionnaire (USE). The independently translated Turkish versions of the questionnaire were then reviewed by an expert panel to reach consensus. This exp

People with low back and neck pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with low back pain and neck pain

You may qualify if:

  • Presence of back or neck pain lasting at least 3 months
  • Use of a supportive biomedical device in a rehabilitation program
  • Literacy
  • Age between 18 and 65
  • Willingness to participate in the study on a voluntary basis

You may not qualify if:

  • \. Malignant condition 2. Pregnancy 3. Loss of function due to neurological or systemic disease 4. Having undergone surgery in the last 6 months 5. Acute infection 6. Unhealed fracture 7. Withdrawal from any phase of the study 8. Light sensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck PainLow Back PainMusculoskeletal Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Özlem Ülger, PT, PhD

    Hacettepe University, Faculty of Physical Therapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdurahim Aslıyüce, PT, PhD cand

CONTACT

Özlem Ülger, PT, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 8, 2025

Study Start

August 26, 2025

Primary Completion

September 1, 2025

Study Completion

September 30, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08