Stroke PatientsNCT05263063
Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Tele-Assessment
An observational study of Stroke Patients, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the reliability and validity of the synchronous and asynchronous application of Berg Balance Scale and Tinetti Balance Test in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Used for Balance Assessment in Individuals With Chronic Stroke
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2022to 16 Aug 2023
- How long will I take part?
- 3 Days
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The stroke patients to be included in the study will be selected from among the stroke individuals who applied to Hacettepe University, Faculty of Physical Therapy and Rehabilitation for routine physiotherapy and rehabilitation practices, and those who were eligible according to the inclusion and exclusion criteria and agreed to participate in the study by signing their consent forms.
Who may be able to join
- have been diagnosed with stroke,
- aged 18 and over,
- literate,
- stroke caused by anterior circulation,
- computer, phone and tablet etc. Having experience in the use of technological devices and experienced caregivers in this regard,
- at least Stage 3 in the lower extremities according to Brunnstrom Recovery Stages,
- A score of 24 and above in the Mini Mental State Test
Who cannot join
- vestibular lesion/dysfunction,
- auditory and visual lesion/dysfunction,
- accompanying neurological disorders (Multiple sclerosis, Parkinson, Ataxia, dystonia, dyskinesia, etc.)
- psychiatric disorders
- patients with aphasia to a degree that causes communication problems will not be included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Used for Balance Assessment
The aim of the study is to examine the reliability and validity of the synchronous and asynchronous application of Berg Balance Scale and Tinetti Balance Test in stroke patients.
Read the detailed description
Two physiotherapists will evaluate stroke patients' balance using the berg balance scale and the Tinetti balance test. Before the evaluation, patients will be informed about the mask, distance, and hygiene issues, which will be considered in the assessment. On the first day, information about the patient and the disease, filling in the patient data form, and face-to-face assessment will be made face to face with the patients. The next day, one synchronous and asynchronous tele-evaluation method will be applied. Evaluations will be made at the same time zone of the day, determined by the randomization method, one day apart. For the learning effect to not positively impact a technique in the assessments, the order of the checks applied to each will change. The first physiotherapist will conduct face-to-face interviews and evaluations in a clinical setting. In the meantime, necessary measures will be taken due to the pandemic. The synchronous tele-assessment will be evaluated online in real-time by the second physiotherapist. At the same time, the first physiotherapist will make their evaluations online without giving instructions during this evaluation. For asynchronous tele-assessment, a reference evaluation video will be sent to the patients. Relatives of the patients will be asked to watch this video, make the evaluation and take a video recording at the same time. Then, these video recordings will be evaluated separately by the first and second physiotherapists, and the results will be compared. Each assessment will take approximately 30 minutes. The test evaluation will be performed again. Asynchronous tele-evaluation videos will also be re-evaluated in 25% of individuals after ten days. This way, instead of having the patients repeat the same tests, the test will be repeated on the first test.
- Conditions
- Stroke Patients
- Being tested
- Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Used for Balance Assessment in Individuals With Chronic Stroke
- Keywords
- Stroke, Balance, Synchronous tele-assessment, Asynchronous tele-assessment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Used for Balance Assessment in Individuals With Chronic StrokeOther
On the first day, information about the patient and the disease, filling in the patient data form and face-to-face evaluation will be made face to face with the patients. The next day, one of the synchronous and asynchronous tele-evaluation methods will be applied. Face-to-face interview and face-to-face evaluation will be made by the first physiotherapist in a clinical setting. The synchronous tele-assessment will be evaluated online in real time by the second physiotherapist. For asynchronous tele-assessment, a reference evaluation video will be sent to the patients. Relatives of the patients will be asked to watch this video, make the evaluation and take a video recording at the same time. Then, these video recordings will be evaluated separately by the first and second physiotherapists and the results will be compared. Each assessment will take approximately 30 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Berg balance scale is a 14-item scale that evaluates the tasks frequently used in daily living activities. Standing without sitting, sitting without support, standing without support, sitting standing, transfers, standing with eyes closed, standing with legs together, reaching forward while standing, picking up objects from the ground, looking back from both sides, turning 360 degrees, stepping alternately It includes functions such as picking up, standing with one foot forward and standing on one foot. Each item is scored between 0-4; 0 indicates that the individual could not fulfill the task, and 4 indicates that he was successful in the task. The total score of the test is between 0-56. 0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: independent ambulation
Measured: 15 minutes
Secondary outcomes (4)
Tinetti Balance Scale
The Tinetti Balance Test was used to evaluate the balance functions of stroke patients. The balance test includes sitting balance, standing and standing balance, evaluation of balance with eyes open and closed, 360 degree rotation around itself and evaluation of reaching. The questions are scored between 0-2 and a maximum of 26 points can be obtained for balance. A total score of 18 and below indicates a high risk of falling, a score of 19-24 indicates a moderate fall risk, and a score of 24 and above indicates a low risk of falling.
Measured: 10 minutes
Foot Pressure Distribution and Postural Oscillations
Foot pressure distribution and postural oscillations of individuals will be evaluated using FreeMed baropodometric platform (SensorMedica, Roma) and Free Step software with 120 cmx50cm dimensions and 400Hz sampling frequency. The evaluation time of the device is 5s for baropodometry and 31s for stabilometry.
Measured: 5 minutes
Stroke Rehabilitation Assessment of Movement Scale
Motor movement and mobility level will be evaluated with the Stroke Rehabilitation Assessment of Movement Scale . The Stroke Rehabilitation Assessment of Movement Scale consists of 3 lower scales (voluntary motor movement ability of the upper and lower extremities and basic mobility ability) each of which includes 10 items. While calculating the upper and lower extremities from 20 points in total; mobility is 30 points in total. It has been reported as a valid and reliable method in clinical practice and research in stroke.
Measured: 10 minutes
Modified Ashworth Scale
Modified Ashworth Scale will be used to evaluate muscle tone. The increase in muscle tone occurs with the resistance of the joints to passive movement (29). In this scale, scores are made between 0 (normal muscle tone) and 5 (rigid in extremity flexion or extension). Studies show the validity and reliability of the Modified Ashworth Scale in the assessment of muscle tone.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start28 Jun 2022
- Primary completion28 Apr 2023
- Study completion16 Aug 2023
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 Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- 36 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birol Önal, Hacettepe University
- Investigators
- Birol Önal, Principal investigator, Hacettepe Univeristy Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263063
- Sponsor's protocol ID
- strokeandteleassesment
- Status last verified
- Sep 2023
- First submitted
- 21 Feb 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Onal B, Kose N, Onal SN, Zengin HY. Validity and Reliability of the Berg Balance Scale in Different Tele-Assessment Methods in Patients With Stroke. J Eval Clin Pract. 2025 Jun;31(4):e70141. doi: 10.1111/jep.70141.
PubMed 40492944
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Used for Balance Assessment
- ClinicalTrials.gov ID
- NCT05263063
- Acronym / sponsor ID
- strokeandteleassesment
- Conditions
- Stroke Patients
- Keywords
- Stroke, Balance, Synchronous tele-assessment, Asynchronous tele-assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 2 Mar 2022 (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.
The aim of the study is to examine the reliability and validity of the synchronous and asynchronous application of Berg Balance Scale and Tinetti Balance Test in stroke patients.
Detailed description
Two physiotherapists will evaluate stroke patients' balance using the berg balance scale and the Tinetti balance test. Before the evaluation, patients will be informed about the mask, distance, and hygiene issues, which will be considered in the assessment. On the first day, information about the patient and the disease, filling in the patient data form, and face-to-face assessment will be made face to face with the patients. The next day, one synchronous and asynchronous tele-evaluation method will be applied. Evaluations will be made at the same time zone of the day, determined by the randomization method, one day apart. For the learning effect to not positively impact a technique in the assessments, the order of the checks applied to each will change. The first physiotherapist will conduct face-to-face interviews and evaluations in a clinical setting. In the meantime, necessary measures will be taken due to the pandemic. The synchronous tele-assessment will be evaluated online in real-time by the second physiotherapist. At the same time, the first physiotherapist will make their evaluations online without giving instructions during this evaluation. For asynchronous tele-assessment, a reference evaluation video will be sent to the patients. Relatives of the patients will be asked to watch this video, make the evaluation and take a video recording at the same time. Then, these video recordings will be evaluated separately by the first and second physiotherapists, and the results will be compared. Each assessment will take approximately 30 minutes. The test evaluation will be performed again. Asynchronous tele-evaluation videos will also be re-evaluated in 25% of individuals after ten days. This way, instead of having the patients repeat the same tests, the test will be repeated on the first test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The stroke patients to be included in the study will be selected from among the stroke individuals who applied to Hacettepe University, Faculty of Physical Therapy and Rehabilitation for routine physiotherapy and rehabilitation practices, and those who were eligible according to the inclusion and exclusion criteria and agreed to participate in the study by signing their consent forms.
Key inclusion criteria (7 listed)
- have been diagnosed with stroke,
- aged 18 and over,
- literate,
- stroke caused by anterior circulation,
- computer, phone and tablet etc. Having experience in the use of technological devices and experienced caregivers in this regard,
Key exclusion criteria (5 listed)
- vestibular lesion/dysfunction,
- auditory and visual lesion/dysfunction,
- accompanying neurological disorders (Multiple sclerosis, Parkinson, Ataxia, dystonia, dyskinesia, etc.)
- psychiatric disorders
- patients with aphasia to a degree that causes communication problems will not be included.
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 |
|---|---|---|
| Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Used for Balance Assessment in Individuals With Chronic StrokeOn the first day, information about the patient and the disease, filling in the patient data form and face-to-face evaluation will be made face to face with the patients. The next day, one of the synchronous and asynchronous tele-evaluation methods will be applied. Face-to-face interview and face-to-face evaluation will be made by the first physiotherapist in a clinical setting. The synchronous tele-assessment will be evaluated online in real time by the second physiotherapist. For asynchronous tele-assessment, a reference evaluation video will be sent to the patients. Relatives of the patients will be asked to watch this video, make the evaluation and take a video recording at the same time. Then, these video recordings will be evaluated separately by the first and second physiotherapists and the results will be compared. Each assessment will take approximately 30 minutes. | Other | – |
Primary outcome
Berg Balance Scale
Time frame: 15 minutes
Berg balance scale is a 14-item scale that evaluates the tasks frequently used in daily living activities. Standing without sitting, sitting without support, standing without support, sitting standing, transfers, standing with eyes closed, standing with legs together, reaching forward while standing, picking up objects from the ground, looking back from both sides, turning 360 degrees, stepping alternately It includes functions such as picking up, standing with one foot forward and standing on one foot. Each item is scored between 0-4; 0 indicates that the individual could not fulfill the task, and 4 indicates that he was successful in the task. The total score of the test is between 0-56. 0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: independent ambulation
4 secondary outcomes
Tinetti Balance Scale
Time frame: 10 minutes
Foot Pressure Distribution and Postural Oscillations
Time frame: 5 minutes
Stroke Rehabilitation Assessment of Movement Scale
Time frame: 10 minutes
Modified Ashworth Scale
Time frame: 5 minutes
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 15 Sep 2023.
- Derived from this study: PubMed 40492944Onal B, Kose N, Onal SN, Zengin HY. Validity and Reliability of the Berg Balance Scale in Different Tele-Assessment Methods in Patients With Stroke. J Eval Clin Pract. 2025 Jun;31(4):e70141. doi: 10.1111/jep.70141.
Related trials for Stroke Patients
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy
Acute Ischemic Stroke
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.
Birol Önal principal investigator
Hacettepe Univeristy Faculty of Physical Therapy and Rehabilitation
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 Stroke Patients, run by Hacettepe 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 7 inclusion and 5 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 15 Sep 2023. 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?
Berg Balance Scale (time frame: 15 minutes). 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 NCT05263063, 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 15 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.