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

March 10, 2021 updated by: Ceren Bayrak, Istanbul University - Cerrahpasa (IUC)

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?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

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 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 (Anticipated)

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.
50

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.

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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

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 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.
12 weeks
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.
12 weeks
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.
12 weeks

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.
Istanbul University - Cerrahpasa (IUC)

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: 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

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 (Anticipated)

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.
March 1, 2021

Primary Completion (Anticipated)

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.
June 1, 2021

Study Completion (Anticipated)

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.
September 1, 2021

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).
March 8, 2021

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.
March 10, 2021

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 11, 2021

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.
March 12, 2021

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.
March 10, 2021

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.
March 1, 2021

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.
  • IstanbulUC7

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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