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

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05263063
Collaborator
(none)
40
1
8
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Used for Balance Assessment in Individuals With Chronic Stroke

Detailed Description

The balance of stroke patients will be evaluated by two physiotherapists using the berg balance scale and the tinetti balance test. Before the evaluation, patients will be informed about the mask, distance and hygiene issues, and these conditions will be taken into consideration during the evaluation.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. Evaluations will be made at the same time zone of the day, determined by the randomization method, one day apart. In order for the learning effect to not have a positive effect on a method in the assessments, the order of the assessments applied to each individual will change.Face-to-face interview and face-to-face evaluation will be made by the first physiotherapist 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.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.For reliability, 25% of the individuals will be recorded during the synchronous tele-assessment, and this record will be examined 10 days after the person's evaluation time, and the test evaluation will be performed again. Asynchronous tele-evaluation videos will also be re-evaluated after 10 days in 25% of individuals. In this way, instead of having the patients do the same tests again, the test will be repeated on the first tests.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Comparison of Face-to-face, Synchronous and Asynchronous Use of Methods Used for Balance Assessment
Anticipated Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Aug 28, 2022
Anticipated Study Completion Date :
Oct 28, 2022

Outcome Measures

Primary Outcome Measures

  1. Berg Balance Scale [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

Secondary Outcome Measures

  1. Tinetti Balance Scale [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.

  2. Foot Pressure Distribution and Postural Oscillations [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.

  3. Stroke Rehabilitation Assessment of Movement Scale [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.

  4. Modified Ashworth Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Principal Investigator: Birol Önal, Hacettepe Univeristy Faculty of Physical Therapy and Rehabilitation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Birol Önal, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05263063
Other Study ID Numbers:
  • strokeandteleassesment
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Birol Önal, Research Assistant, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022