Tele-assessmentNCT05544422
The Reliability and Validity Tele-assessment of The TUG Test and 30s-CST
A study testing The Timed Up & Go Test and 30second Chair-Stand Test' in people with Tele-assessment and The Timed Up & Go Test, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Stroke is the third leading cause of death in the world after coronary heart disease and cancer. In recent years, by controlling the risk factors of stroke, its incidence has decreased by 30% and the mortality rate due to this disease has decreased by 14%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tele-assessment, The Timed Up & Go Test, Stroke
- What is being tested?
- The Timed Up & Go Test and 30second Chair-Stand Test'
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 15 Dec 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had a stroke at least 6 months ago
- be between the ages of 18-65
- A Mini Mental Test result of more than 24 points
- Lower extremity score of 5-6 for Brunnstrom
- not have cognitive impairment
- Willingness and volunteering to work
- Having and being able to use a smart mobile device or a computer with a camera
- have an internet package
Who cannot join
- Having a different vestibular and orthopedic problem
- Having a visual or hearing impairment
- Known cardiopulmonary disease
- Having had a transient ischemic attack or multiple stroke
- Lack of independent sitting and standing balance
- have chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability and Validity Tele-assessment of The Timed Up & Go Test and 30second Chair-Stand Test in Patients With Stroke
Stroke is the third leading cause of death in the world after coronary heart disease and cancer. In recent years, by controlling the risk factors of stroke, its incidence has decreased by 30% and the mortality rate due to this disease has decreased by 14%. However, it is still among the most important diseases that cause disability in adults.
The aging of the world population and the increase in the number of individuals with chronic diseases, including stroke, increase the need for rehabilitation services rapidly. Access to rehabilitation services is restricted due to the insufficient number of specialist health personnel and the difficulty of transportation for people living in rural areas. At the same time, barriers such as decrease in physical mobility, increase in bothersome symptoms and travel restrictions in developed countries are expected to increase with the aging population and will cause a decrease in participation in rehabilitation. In this context, telerehabilitation shows a promising way to increase rehabilitation access with fewer healthcare professionals or to help maintain positive outcomes following rehabilitation.
Read more
Telerehabilitation, which is among the telehealth possibilities, is defined as the use of information and communication technologies to provide clinical rehabilitation services remotely. These technologies allow communication between healthcare personnel and patients, as well as the transmission of imaging and other healthcare data from one place to another. Telerehabilitation includes clinical rehabilitation services focused on evaluation, diagnosis and treatment (Janet vd.,). Tele-assessment, which is among the service delivery model of telerehabilitation, is defined as the transfer of patient data to the healthcare professional or team, instantly or retrospectively, through equipment, sensors, questionnaires and tests. Unlike other services, there are factors that make tele-assessment difficult. It is necessary to ensure that patient performance is correctly evaluated. Internet and video transmission can affect the ability to accurately assess patient performance and thus affect the tele-assessment. Consideration should be given to the validation of tele-assessment for certain assessments that are frequently used in the assessment of patient performance. For this reason, we chose to examine the timed 'Up \& Go'(TUG) test and '30second Chair-Stand Test' (30s-CST), which are the most common tests in the evaluation of lower extremity muscle strength, balance, and mobility in rehabilitation.
TUG and 30s-CST are simple clinical outcome measures commonly used to assess functional performance. Johansen et al. found that the TUG test and 30s-CST in stroke patients had excellent internal and inter-research reliability when administered face-to-face. This study is based on studies showing that the application of tests that are effective in the evaluation of functional performance with the tele-assessment method is an effective method.
- Being tested
- The Timed Up & Go Test and 30second Chair-Stand Test'
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Timed Up & Go Test and 30second Chair-Stand Test'Other
Evaluation of the participants will be carried out in the following order; 1) traditional assessment, 2) tele-assessment, 3) post-test. In the final test, only tele-assessment of the tests will be made.
During testing sessions, the results of each TUG and 30s-CST trial will be recorded on a standard test paper. TUG and 30s-CST will be tested in two different ways, traditional and tele, as 2 sessions every other day. Participants will rest for five to ten minutes between trials and an hour between sessions. During the one-hour rest between two test sessions, participants will rest in a chair, wheelchair or bed. Assessors will not know the TUG and 30s-CST results scored by each other.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Other | The Timed Up \& Go Test and 30-second Chair-Stand Tests with conventional and tele-assessment methods will be applied to the participants included in the study. Receives: Other: The Timed Up & Go Test and 30second Chair-Stand Test' |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Timed Up & Go Test
It is a measurement that evaluates functional mobility, dynamic balance, fall risk and postural stability that can be applied for different purposes in different age and patient groups. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The ZQM test measures the time it takes for an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit back down.
Measured: 2 week
The 30-second Chair Stand Test
In a chair with a sitting height of 43.2 cm and a back supported, the patient is asked to sit and stand as quickly as possible. The patient sits in the chair. They cross their hands on their chest. Before the test, 2 attempts are made. The number of sitting down times is noted by keeping a 30-second timer with a stopwatch. Less than 10 sit-ups in 30 seconds indicates lower extremity muscle weakness.
Measured: 2 week
The 6 minute walk test
The individual is asked to walk on a certain track for 6 minutes. The test is performed in a closed area, on a flat surface of 30 m in length and under the supervision of the evaluator. After six minutes, the total distance walked is recorded in meters.
Measured: 2 week
Secondary outcomes (3)
The Tinetti Balance and Gait test
It evaluates balance ability and gait under 2 main headings: the first 9 questions are about balance and the next 7 questions are about walking. Calculation of the survey score; The total score of the first 9 items gives the balance score, the total score of the next 7 items gives the walking score, and the sum of the balance and walking scores gives the total score. Item 16 is the whole of the actions done during ADL. As a result of the evaluation made by observation, the scoring is as follows: 2 points; correct execution of the indicated movement, 1 point; performing the specified movement with adaptations, 0 points; failure to move. If the total score of the scale is 18 and below, the risk of falling is high, if it is 19-24, the risk of falling is moderate, and if it is 24 and above, the risk of falling is low.
Measured: 2 week
The Functional Independence Measure
This scale, which is used to evaluate the level of physical activity, is an 18-item scale that evaluates 4 physical and 2 cognitive domains and consists of 6 subsections. Each item is scored between 1-7 (1: Fully assisted, 7: Completely independent), the total score varies between 18-126 (fully dependent-fully independent).
Measured: 2 week
Mini-Mental State Examination
It is a screening test used to evaluate the cognitive status of cases. It consists of 11 items gathered under 5 main headings: orientation, recording memory, attention and calculation, recall and language. Evaluation is made out of a total of 30 points
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start15 Oct 2022
- Primary completion15 Nov 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tele-assessmentStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544422
- Sponsor's protocol ID
- 4
- Status last verified
- Jun 2024
- First submitted
- 9 Aug 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity Tele-assessment of The Timed Up & Go Test and 30second Chair-Stand Test in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05544422
- Acronym / sponsor ID
- 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 16 Sep 2022 (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.
Stroke is the third leading cause of death in the world after coronary heart disease and cancer. In recent years, by controlling the risk factors of stroke, its incidence has decreased by 30% and the mortality rate due to this disease has decreased by 14%. However, it is still among the most important diseases that cause disability in adults.
The aging of the world population and the increase in the number of individuals with chronic diseases, including stroke, increase the need for rehabilitation services rapidly. Access to rehabilitation services is restricted due to the insufficient number of specialist health personnel and the difficulty of transportation for people living in rural areas. At the same time, barriers such as decrease in physical mobility, increase in bothersome symptoms and travel restrictions in developed countries are expected to increase with the aging population and will cause a decrease in participation in rehabilitation. In this context, telerehabilitation shows a promising way to increase rehabilitation access with fewer healthcare professionals or to help maintain positive outcomes following rehabilitation.
Telerehabilitation, which is among the telehealth possibilities, is defined as the use of information and communication technologies to provide clinical rehabilitation services remotely. These technologies allow communication between healthcare personnel and patients, as well as the transmission of imaging and other healthcare data from one place to another. Telerehabilitation includes clinical rehabilitation services focused on evaluation, diagnosis and treatment (Janet vd.,). Tele-assessment, which is among the service delivery model of telerehabilitation, is defined as the transfer of patient data to the healthcare professional or team, instantly or retrospectively, through equipment, sensors, questionnaires and tests. Unlike other services, there are factors that make tele-assessment difficult. It is necessary to ensure that patient performance is correctly evaluated. Internet and video transmission can affect the ability to accurately assess patient performance and thus affect the tele-assessment. Consideration should be given to the validation of tele-assessment for certain assessments that are frequently used in the assessment of patient performance. For this reason, we chose to examine the timed 'Up \& Go'(TUG) test and '30second Chair-Stand Test' (30s-CST), which are the most common tests in the evaluation of lower extremity muscle strength, balance, and mobility in rehabilitation.
TUG and 30s-CST are simple clinical outcome measures commonly used to assess functional performance. Johansen et al. found that the TUG test and 30s-CST in stroke patients had excellent internal and inter-research reliability when administered face-to-face. This study is based on studies showing that the application of tests that are effective in the evaluation of functional performance with the tele-assessment method is an effective method.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Other | Other: The Timed Up & Go Test and 30second Chair-Stand Test'The Timed Up \& Go Test and 30-second Chair-Stand Tests with conventional and tele-assessment methods will be applied to the participants included in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have had a stroke at least 6 months ago
- be between the ages of 18-65
- A Mini Mental Test result of more than 24 points
- Lower extremity score of 5-6 for Brunnstrom
- not have cognitive impairment
Key exclusion criteria (6 listed)
- Having a different vestibular and orthopedic problem
- Having a visual or hearing impairment
- Known cardiopulmonary disease
- Having had a transient ischemic attack or multiple stroke
- Lack of independent sitting and standing balance
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 |
|---|---|---|
| The Timed Up & Go Test and 30second Chair-Stand Test'Evaluation of the participants will be carried out in the following order; 1) traditional assessment, 2) tele-assessment, 3) post-test. In the final test, only tele-assessment of the tests will be made. During testing sessions, the results of each TUG and 30s-CST trial will be recorded on a standard test paper. TUG and 30s-CST will be tested in two different ways, traditional and tele, as 2 sessions every other day. Participants will rest for five to ten minutes between trials and an hour between sessions. During the one-hour rest between two test sessions, participants will rest in a chair, wheelchair or bed. Assessors will not know the TUG and 30s-CST results scored by each other. | Other | Study Group |
Primary outcome
The Timed Up & Go Test
Time frame: 2 week
It is a measurement that evaluates functional mobility, dynamic balance, fall risk and postural stability that can be applied for different purposes in different age and patient groups. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The ZQM test measures the time it takes for an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit back down.
The 30-second Chair Stand Test
Time frame: 2 week
In a chair with a sitting height of 43.2 cm and a back supported, the patient is asked to sit and stand as quickly as possible. The patient sits in the chair. They cross their hands on their chest. Before the test, 2 attempts are made. The number of sitting down times is noted by keeping a 30-second timer with a stopwatch. Less than 10 sit-ups in 30 seconds indicates lower extremity muscle weakness.
The 6 minute walk test
Time frame: 2 week
The individual is asked to walk on a certain track for 6 minutes. The test is performed in a closed area, on a flat surface of 30 m in length and under the supervision of the evaluator. After six minutes, the total distance walked is recorded in meters.
3 secondary outcomes
The Tinetti Balance and Gait test
Time frame: 2 week
The Functional Independence Measure
Time frame: 2 week
Mini-Mental State Examination
Time frame: 2 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Timed Up & Go Test and 30second Chair-Stand Test' in people with Tele-assessment and The Timed Up & Go Test, run by Istinye University at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Timed Up & Go Test (time frame: 2 week). 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 4 Jun 2024.