StrokeNCT04793594
Which Balance Test is More Effective When Evaluating Stroke Patients With a Tele-assessment?
An observational study of Stroke, run by Istanbul University - Cerrahpasa.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Berg Balance Test, Tinetti Balance And Gait Test and Time Up And Go Test
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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?
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Berg Balance Test, Tinetti Balance And Gait Test, Time Up And Go Test
- Keywords
- Tele-assessment, Balance, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berg Balance TestOther
Patients evaluate with Berg Balance Test for balance
Tinetti Balance And Gait TestOther
Patients evaluate with Tinetti Balance And Gait Test for balance
Time Up And Go TestOther
Patients evaluate with Time Up And Go Test for balance
| Study group | Role | What they receive |
|---|---|---|
| Tele- Assessment Group | Balance Assessment Receives: Other: Berg Balance Test; Other: Tinetti Balance And Gait Test; Other: Time Up And Go Test | |
| Face To Face (Clinic) Group | Balance Assessment Receives: Other: Berg Balance Test; Other: Tinetti Balance And Gait Test; Other: Time Up And Go Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Test
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.
Measured: 12 weeks
Tinetti Balance And Gait Scale
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.
Measured: 12 weeks
Timed Up And Go Test
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Bayrak, Istanbul University - Cerrahpasa
- Investigators
- Ceren Bayrak, BSc, Principal investigator, Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation DepartmentAyse Zengin Alpozgen, PhD, Study chair, Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation DepartmentYakup Krespi, Professor, Principal investigator, Istinye University, Faculty of Medicine, Neurology DepartmentRoya Soltanalizadeh, MD, Principal investigator, Istinye University Bahcesehir Liv Hospitalİlknur Mazı, BSc, Principal investigator, Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793594
- Sponsor's protocol ID
- IstanbulUC7
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04793594
- Acronym / sponsor ID
- IstanbulUC7
- Conditions
- Stroke
- Keywords
- Tele-assessment, Balance, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele- Assessment Group | – | Other: Berg Balance Test, Other: Tinetti Balance And Gait Test, Other: Time Up And Go TestBalance Assessment |
| Face To Face (Clinic) Group | – | Other: Berg Balance Test, Other: Tinetti Balance And Gait Test, Other: Time Up And Go TestBalance Assessment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berg Balance TestPatients evaluate with Berg Balance Test for balance | Other | Face To Face (Clinic) Group, Tele- Assessment Group |
| Tinetti Balance And Gait TestPatients evaluate with Tinetti Balance And Gait Test for balance | Other | Face To Face (Clinic) Group, Tele- Assessment Group |
| Time Up And Go TestPatients evaluate with Time Up And Go Test for balance | Other | Face To Face (Clinic) Group, Tele- Assessment Group |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceren Bayrak, BSc principal investigator
Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department
Ayse Zengin Alpozgen, PhD study chair
Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department
Yakup Krespi, Professor principal investigator
Istinye University, Faculty of Medicine, Neurology Department
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayse Zengin Alpozgen, PhD (05526830479, azengin@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Test (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.