Neurological DiseaseNCT05970939
Development, Reliability and Validity of the Telerehabilitation Usability Questionnaire- TrUQ
An observational study of Neurological Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Neurological diseases are central nervous system diseases that cause an increase in the level of disability and limitations in daily life. Multiple Sclerosis (MS), stroke, and Parkinson's Disease (PD) are among the most common apparent neurological diseases, and epidemiological studies show that their prevalence has… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurological Disease
- What is being tested?
- Development of the Telerehabilitation Usability Questionnaire
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2023to 28 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Neurological patients receiving physiotherapy and rehabilitation via telerehabilitation
Who may be able to join
- Voluntarily participate in research to accept
- Mini-Mental Test score more than or equal 24
- Previously receiving physical therapy through telerehabilitation
Who cannot join
- Any visual, hearing, and perception problems that may affect the answering the questionnaire items
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Reliability and Validity of the Telerehabilitation Usability Questionnaire- TrUQ in Neurological Diseases
Neurological diseases are central nervous system diseases that cause an increase in the level of disability and limitations in daily life. Multiple Sclerosis (MS), stroke, and Parkinson's Disease (PD) are among the most common apparent neurological diseases, and epidemiological studies show that their prevalence has increased over time worldwide. Although MS, stroke, and PD have different causes and neurological aspects, they generally cause motor, sensory, and/or cognitive impairments, leading to restriction of the individual's activities and participation. Today, physiotherapy and rehabilitation approaches together with optimal medical and surgical treatment are the cornerstones of treatment for these diseases. Recently, it has been stated that various telerehabilitation interventions in the field of physiotherapy and rehabilitation may be an additional option to the rehabilitation approaches applied in the clinic. On the other hand, It is important to evaluate the level of usability in expanding the usability of telerehabilitation services and determining the best telerehabilitation service. For this reason, there is a need for questionnaires investigating the satisfaction level of physiotherapy and rehabilitation applied through telerehabilitation.
Read the detailed description
Questionnaire items will be created in two stages. First, 5 experts will independently review the literature on "telerehabilitation" and "usability". In addition, these experts will be asked to create a pool of questions based on their experiences in telerehabilitation and by taking the opinions of patients receiving telerehabilitation about usability. Then, 5 experts will come together and obtain a single question pool containing the questions they deem important in their question pool. The second step will involve scaling the elements. In this study, scale items will be scored on a five-point Likert scale, ranging from 1, strongly disagree to 5, strongly agree. Then, it will be applied to a pilot group of 10 people and it will be evaluated whether the items prepared by the experts are understood by the patients. In line with the expert opinion and the result of the pilot study, the final version of the scale will be decided and applied to MS, PD, and stroke patients who make up the study group. Finally, the validity and reliability of the questionnaire will be calculated.
- Conditions
- Neurological Disease
- Being tested
- Development of the Telerehabilitation Usability Questionnaire
- Keywords
- Multiple Sclerosis, Parkinson Disease, Stroke, Usability, Telerehabilitation
- Medical subject headings
- Nervous System Diseases, Multiple Sclerosis, Parkinson Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development of the Telerehabilitation Usability QuestionnaireOther
This study will be examined the development, validity, and reliability of the Telerehabilitation Usability Questionnaire in patients with MS.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Usability | Telerehabilitation Usability Group Receives: Other: Development of the Telerehabilitation Usability Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telerehabilitation Usability Questionnaire in patients with Neurological disease
Patients get a minimum of 0 points (best condition) and a maximum of 4 points (worst condition) for each question on this scale
Measured: Baseline
Telerehabilitation Usability Questionnaire in patients with Neurological disease-Second
Patients get a minimum of 0 points (best condition) and a maximum of 4 points (worst condition) for each question on this scale
Measured: he second assessment will be conducted after the one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start28 Jul 2023
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurological DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kader Eldemir, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970939
- Sponsor's protocol ID
- ND-Development-TrUQ
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
PubMed 27563386
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Reliability and Validity of the Telerehabilitation Usability Questionnaire- TrUQ in Neurological Diseases
- ClinicalTrials.gov ID
- NCT05970939
- Acronym / sponsor ID
- ND-Development-TrUQ
- Conditions
- Neurological Disease
- Keywords
- Multiple Sclerosis, Parkinson Disease, Stroke, Usability, Telerehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurological diseases are central nervous system diseases that cause an increase in the level of disability and limitations in daily life. Multiple Sclerosis (MS), stroke, and Parkinson's Disease (PD) are among the most common apparent neurological diseases, and epidemiological studies show that their prevalence has increased over time worldwide. Although MS, stroke, and PD have different causes and neurological aspects, they generally cause motor, sensory, and/or cognitive impairments, leading to restriction of the individual's activities and participation. Today, physiotherapy and rehabilitation approaches together with optimal medical and surgical treatment are the cornerstones of treatment for these diseases. Recently, it has been stated that various telerehabilitation interventions in the field of physiotherapy and rehabilitation may be an additional option to the rehabilitation approaches applied in the clinic. On the other hand, It is important to evaluate the level of usability in expanding the usability of telerehabilitation services and determining the best telerehabilitation service. For this reason, there is a need for questionnaires investigating the satisfaction level of physiotherapy and rehabilitation applied through telerehabilitation.
Detailed description
Questionnaire items will be created in two stages. First, 5 experts will independently review the literature on "telerehabilitation" and "usability". In addition, these experts will be asked to create a pool of questions based on their experiences in telerehabilitation and by taking the opinions of patients receiving telerehabilitation about usability. Then, 5 experts will come together and obtain a single question pool containing the questions they deem important in their question pool. The second step will involve scaling the elements. In this study, scale items will be scored on a five-point Likert scale, ranging from 1, strongly disagree to 5, strongly agree. Then, it will be applied to a pilot group of 10 people and it will be evaluated whether the items prepared by the experts are understood by the patients. In line with the expert opinion and the result of the pilot study, the final version of the scale will be decided and applied to MS, PD, and stroke patients who make up the study group. Finally, the validity and reliability of the questionnaire will be calculated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Usability | – | Other: Development of the Telerehabilitation Usability QuestionnaireTelerehabilitation Usability Group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Neurological patients receiving physiotherapy and rehabilitation via telerehabilitation
Key inclusion criteria (3 listed)
- Voluntarily participate in research to accept
- Mini-Mental Test score more than or equal 24
- Previously receiving physical therapy through telerehabilitation
Key exclusion criteria (1 listed)
- Any visual, hearing, and perception problems that may affect the answering the questionnaire items
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development of the Telerehabilitation Usability QuestionnaireThis study will be examined the development, validity, and reliability of the Telerehabilitation Usability Questionnaire in patients with MS. | Other | Telerehabilitation Usability |
Primary outcome
Telerehabilitation Usability Questionnaire in patients with Neurological disease
Time frame: Baseline
Patients get a minimum of 0 points (best condition) and a maximum of 4 points (worst condition) for each question on this scale
Telerehabilitation Usability Questionnaire in patients with Neurological disease-Second
Time frame: he second assessment will be conducted after the one week
Patients get a minimum of 0 points (best condition) and a maximum of 4 points (worst condition) for each question on this scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 27563386Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
- Reference 1Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Disease, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telerehabilitation Usability Questionnaire in patients with Neurological disease (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05970939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.