Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Tele-Assessment

September 14, 2023 updated by: Birol Önal, Hacettepe University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
15 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tinetti Balance Scale
Time Frame: 10 minutes
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.
10 minutes
Foot Pressure Distribution and Postural Oscillations
Time Frame: 5 minutes
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.
5 minutes
Stroke Rehabilitation Assessment of Movement Scale
Time Frame: 10 minutes
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.
10 minutes
Modified Ashworth Scale
Time Frame: 5 minutes
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.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Birol Önal, Hacettepe Univeristy Faculty of Physical Therapy and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • strokeandteleassesment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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