- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793594
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Anticipated)
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
- Name: Ayse Zengin Alpozgen, PhD
- Phone Number: 05526830479
- Email: azengin@iuc.edu.tr
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
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 |
Intervention / Treatment |
|---|---|
|
Tele- Assessment Group
Balance Assessment
|
Patients evaluate with Berg Balance Test for balance
Patients evaluate with Tinetti Balance And Gait Test for balance
Patients evaluate with Time Up And Go Test for balance
|
|
Face To Face (Clinic) Group
Balance Assessment
|
Patients evaluate with Berg Balance Test for balance
Patients evaluate with Tinetti Balance And Gait Test for balance
Patients evaluate with Time Up And Go Test for balance
|
What is the study measuring?
Primary Outcome Measures
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.
Investigators
- 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)
March 1, 2021
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
September 1, 2021
Study Registration Dates
First Submitted
March 8, 2021
First Submitted That Met QC Criteria
March 10, 2021
First Posted (Actual)
March 11, 2021
Study Record Updates
Last Update Posted (Actual)
March 12, 2021
Last Update Submitted That Met QC Criteria
March 10, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
Clinical Trials on Berg Balance Test
-
The University of Texas Health Science Center,...Texas Woman's UniversityCompletedTraumatic Brain Injury | Acquired Brain Injury | Accidental FallsUnited States
-
Istanbul Medeniyet UniversityUnknown
-
Istanbul Medeniyet UniversityUnknownStroke | Balance; DistortedTurkey
-
T.C. ORDU ÜNİVERSİTESİCompletedRehabilitation | Total Hip Replacement | Reproducibility of ResultsTurkey
-
Gazi UniversityUnknown
-
Clalit Health ServicesUnknownElderly | Falls | Postural BalanceIsrael
-
Istanbul Medeniyet UniversityUnknownSarcopenia | Osteoporosis, Postmenopausal | Balance; DistortedTurkey
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)CompletedPhysical Activity | Parkinson Disease | Balance | Falling | KinesiophobiaTurkey
-
Gazi UniversityCompletedMultiple Sclerosis, Relapsing-RemittingTurkey