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Which Balance Test is More Effective When Evaluating Stroke Patients With a Tele-assessment?

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ClinicalTrials.gov Identifier: NCT04793594
Recruitment Status : Not yet recruiting
First Posted : March 11, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Ceren Bayrak, Istanbul University-Cerrahpasa

Study Description
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Brief Summary:
The aim of this study is to compare the feasibility levels and advantages of balance tests applied with tele-assessment methods to clinical application methods in stroke patients and to reveal their effectiveness.

Condition or disease Intervention/treatment
Stroke Other: Berg Balance Test Other: Tinetti Balance And Gait Test Other: Time Up And Go Test

Detailed Description:
The aim of this study is to compare the feasibility levels and advantages of balance tests applied with tele-assessment methods to clinical application methods in stroke patients and to reveal their effectiveness. Stroke patients who are referred to İstinye University Bahçeşehir Liv Hospital Physiotherapy and Rehabilitation Unit at March-September for physiotherapy and meet the inclusion criteria will be included in the study. The Patient Assessment Form which were prepared by the researcher and the Standardized Mini Mental Test, The Rankin Scale, Timed Get Up and Go Test, Berg Balance Scale, Tinetti Balance and Gait Test in order to evaluate the balance and walking of the participants due to stroke and to compare the applicability level of the tests applied with the tele- assessment method and tests will be completed by individuals who agreed to participate in the study and / or the researchers who carried out the study.
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tele-Assessment in Patients With Stroke: Which of the Berg Balance Scale, Tinetti Balance and Walk Test, Timed Up and Go Tests is More Effective in Balance Assessment?
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Groups and Cohorts
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Group/Cohort Intervention/treatment
Tele- Assessment Group
Balance Assessment
 Other: Berg Balance Test
Patients evaluate with Berg Balance Test for balance

Other: Tinetti Balance And Gait Test
Patients evaluate with Tinetti Balance And Gait Test for balance

Other: Time Up And Go Test
Patients evaluate with Time Up And Go Test for balance
Face To Face (Clinic) Group
Balance Assessment
 Other: Berg Balance Test
Patients evaluate with Berg Balance Test for balance

Other: Tinetti Balance And Gait Test
Patients evaluate with Tinetti Balance And Gait Test for balance

Other: Time Up And Go Test
Patients evaluate with Time Up And Go Test for balance


Outcome Measures
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Primary Outcome Measures :
  1. Berg Balance Test [ Time Frame: 12 weeks ]
    Berg Balance Test is consisting of 14 items and measures the ability of individuals to maintain balance while performing functional tasks. Each task is scored from 0 (cannot perform independently) to 4 (stated best performance). 0-20 points are interpreted as high risk of falling, between 21-40 points as medium risk of falling, and between 41-56 points as low risk. The validity and reliability study of the Turkish version in stroke patients was performed by Şahin et al.

  2. Tinetti Balance And Gait Scale [ Time Frame: 12 weeks ]
    Tinetti Balance And Gait Scale is a total of 28 points, with a maximum of 16 and a walking score of 12 points. Those who score 26 and below are thought to have problems; It is observed that the risk of self-falling is five times higher in those who score 19 and below compared to normal individuals (17). Its adaptation to Turkish, validity and reliability study was carried out by Ağırcan in 2009.

  3. Timed Up And Go Test [ Time Frame: 12 weeks ]
    Timed Up And Go Test is a simply and widely used and rapid test for assessing mobility and dinamic balance. The person is asked to stand up from the chair, walk 3 meters safely and at a normal pace, turn around, walk back, sit back on the chair, and the time is recorded in seconds (sec). The test is started with the patient's feet flat on the floor and arms resting on the armrest of the chair, and is performed in three repetitions and the best result is recorded. Walking longer than 12 seconds indicates a risk of falling.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off.
Criteria

Inclusion Criteria:

  • Sufficient cognitive function for communication (Standardized Mini-Mental Test score> 24)
  • Not dependent on bed or wheelchair. (1 ≤ Modified Rankin Scale score <5)
  • Balance problem (Timed Get Up and Go Test score> 12 sec)
  • Providing the necessary technological competence for remote video communication at home
  • Near a relative who can accompany you during the assessment
  • Age 20-80 years
  • Speaking Turkish

Exclusion Criteria:

  • Individuals with a neurological and orthopedic disease other than stroke, whose vision and auditory function are affected by stroke, and those with aphasia will not be included in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793594


Contacts
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Contact: Ayse Zengin Alpozgen, PhD 05526830479 azengin@iuc.edu.tr

Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: Ceren Bayrak, BSc Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department
Study Chair: Ayse Zengin Alpozgen, PhD Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department
Principal Investigator: Yakup Krespi, Professor Istinye University, Faculty of Medicine, Neurology Department
Principal Investigator: Roya Soltanalizadeh, MD Istinye University Bahcesehir Liv Hospital
Principal Investigator: İlknur Mazı, BSc Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department
More Information
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Responsible Party: Ceren Bayrak, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04793594    
Other Study ID Numbers: IstanbulUC7
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ceren Bayrak, Istanbul University-Cerrahpasa:
Tele-assessment
Balance
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases