Stroke, IschemicEncephaLogNCT06950554
Validity and Reliablity of i-TUG Via EncephaLog
An observational study of Stroke, Ischemic and Balance Assessment, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the test-retest reliability and construct validity of the i-TUG, standard TUG, and Berg Balance Scale (BBS) using the EncephaLog smartphone application in individuals with chronic ischemic stroke. A total of 49 participants were assessed in two sessions to evaluate test-retest reliability. Read more about this study
- Who is it for?
- Ages 18 to 75 days
- Conditions the study is for
- Stroke, Ischemic, Balance Assessment, Smartphones
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2024to 5 Apr 2025
- 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 18 to 75 days
- All sexes
- No healthy volunteers
- Child
Study population: ischemic stroke patients
Who may be able to join
- voluntary participation, a diagnosis of stroke, no involvement in any physiotherapy program for at least three months prior to the study, age between 18 and 75 years, the ability to walk independently Functional Ambulation Scale (FAS) score greater than 3, and the spasticity of the m. gastrocnemius was graded as 2 or less on the Modified Ashworth Scale (MAS).
Who cannot join
- Participants were excluded if they had severe visual or cognitive impairments, severe cardiovascular disease, or musculoskeletal conditions or skin disorders that affected the lower extremities.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Eyupsultan, 34250
About this study
Official title: From Clinic to Smartphone: Evaluating the i-TUG for Balance and Fall Risk in Chronic Stroke
This study investigated the test-retest reliability and construct validity of the i-TUG, standard TUG, and Berg Balance Scale (BBS) using the EncephaLog smartphone application in individuals with chronic ischemic stroke. A total of 49 participants were assessed in two sessions to evaluate test-retest reliability. Construct validity was analyzed using Pearson correlation coefficients. Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC) values were also calculated.
Read the detailed description
The study was conducted with 37 individuals diagnosed with chronic ischemic stroke. Participants were assessed using the i-TUG, TUG, BBS, and additional postural sway parameters collected via EncephaLog. Two test sessions were conducted to assess test-retest reliability. Pearson correlation coefficients were used to evaluate construct validity, and the Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC) were also calculated.
Inclusion Criteria:
- voluntary participation,
- a diagnosis of stroke, no involvement in any physiotherapy program for at least three months prior to the study,
- age between 18 and 75 years,
- the ability to walk independently Functional Ambulation Scale (FAS) score greater than 3,
- the spasticity of the m. gastrocnemius was graded as 2 or less on the Modified Ashworth Scale (MAS).
Exclusion Criteria:
- severe visual or cognitive impairments,
- severe cardiovascular disease, or musculoskeletal conditions or skin disorders that affected the lower extremities.
- Conditions
- Stroke, Ischemic, Balance Assessment, Smartphones
- Keywords
- Stroke, Balance, Berg balance scale, Rehabilitation, EncephaLog
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EncephaLog Assessment Group | The EncephaLog is an FDA-cleared, smartphone-based application designed to assess dynamic balance and gait disorders in older adults and individuals with neurological or non-neurological conditions. The application uses the smartphone' built-in accelerometer and gyroscope to deliver reliable and valid kinematic assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental Timed Up and Go Test (i-TUG) by EncephaLog
The EncephaLog is an FDA-cleared, smartphone-based application designed to assess dynamic balance and gait disorders in older adults and individuals with neurological or non-neurological conditions. The application uses the smartphone' built-in accelerometer and gyroscope to deliver reliable and valid kinematic assessments.
Measured: Day 1 and Day 7
Timed Up and Go Test (TUG)
The TUG test is a commonly used and validated measure to assess balance and mobility. Initially developed for older adults, 29 it has since been widely adopted for neurological and pediatric populations. 30-32 The test requires the participant to rise from a chair, walk 3 meters, turn, return, and sit down. The time to complete the task is recorded. A score greater than 13.5 seconds indicates an increased risk of falling in elderly.
Measured: Day 1 and Day 7
Berg Balance Scale (BBS)
The BBS consists of 14 items designed to assess postural control and fall risk in elderly individuals. 35 Tasks include sitting to standing, standing unsupported, transfers, turning, and stepping. Each item is scored from 0 to 4, and the total score ranges from 0 to 56. A score between 0-20 indicates high fall risk and need for assistive devices; 21-40 indicates moderate fall risk; and 41-56 indicates low fall risk with no need for assistive devices.
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start25 Nov 2024
- Primary completion5 Mar 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve SEVINC GUNDUZ, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950554
- Sponsor's protocol ID
- 12.11.2024-171654
- Acronym
- EncephaLog
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data (i-TUG, TUG, and BBS scores) will be available upon request after publication for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Clinic to Smartphone: Evaluating the i-TUG for Balance and Fall Risk in Chronic Stroke
- ClinicalTrials.gov ID
- NCT06950554
- Acronym / sponsor ID
- EncephaLog / 12.11.2024-171654
- Conditions
- Stroke, Ischemic, Balance Assessment, Smartphones
- Keywords
- Stroke, Balance, Berg balance scale, Rehabilitation, EncephaLog
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 30 Apr 2025 (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.
This study investigated the test-retest reliability and construct validity of the i-TUG, standard TUG, and Berg Balance Scale (BBS) using the EncephaLog smartphone application in individuals with chronic ischemic stroke. A total of 49 participants were assessed in two sessions to evaluate test-retest reliability. Construct validity was analyzed using Pearson correlation coefficients. Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC) values were also calculated.
Detailed description
The study was conducted with 37 individuals diagnosed with chronic ischemic stroke. Participants were assessed using the i-TUG, TUG, BBS, and additional postural sway parameters collected via EncephaLog. Two test sessions were conducted to assess test-retest reliability. Pearson correlation coefficients were used to evaluate construct validity, and the Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC) were also calculated.
Inclusion Criteria:
- voluntary participation,
- a diagnosis of stroke, no involvement in any physiotherapy program for at least three months prior to the study,
- age between 18 and 75 years,
- the ability to walk independently Functional Ambulation Scale (FAS) score greater than 3,
- the spasticity of the m. gastrocnemius was graded as 2 or less on the Modified Ashworth Scale (MAS).
Exclusion Criteria:
- severe visual or cognitive impairments,
- severe cardiovascular disease, or musculoskeletal conditions or skin disorders that affected the lower extremities.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EncephaLog Assessment Group | – | –The EncephaLog is an FDA-cleared, smartphone-based application designed to assess dynamic balance and gait disorders in older adults and individuals with neurological or non-neurological conditions. The application uses the smartphone' built-in accelerometer and gyroscope to deliver reliable and valid kinematic assessments. |
Who may qualify
- Ages
- 18 to 75 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ischemic stroke patients
Key inclusion criteria (1 listed)
- voluntary participation, a diagnosis of stroke, no involvement in any physiotherapy program for at least three months prior to the study, age between 18 and 75 years, the ability to walk independently Functional Ambulation Scale (FAS) score greater than 3, and the spasticity of the m. gastrocnemius was graded as 2 or less on the Modified Ashworth Scale (MAS).
Key exclusion criteria (1 listed)
- Participants were excluded if they had severe visual or cognitive impairments, severe cardiovascular disease, or musculoskeletal conditions or skin disorders that affected the lower extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Instrumental Timed Up and Go Test (i-TUG) by EncephaLog
Time frame: Day 1 and Day 7
The EncephaLog is an FDA-cleared, smartphone-based application designed to assess dynamic balance and gait disorders in older adults and individuals with neurological or non-neurological conditions. The application uses the smartphone' built-in accelerometer and gyroscope to deliver reliable and valid kinematic assessments.
Timed Up and Go Test (TUG)
Time frame: Day 1 and Day 7
The TUG test is a commonly used and validated measure to assess balance and mobility. Initially developed for older adults, 29 it has since been widely adopted for neurological and pediatric populations. 30-32 The test requires the participant to rise from a chair, walk 3 meters, turn, return, and sit down. The time to complete the task is recorded. A score greater than 13.5 seconds indicates an increased risk of falling in elderly.
Berg Balance Scale (BBS)
Time frame: Day 1 and Day 7
The BBS consists of 14 items designed to assess postural control and fall risk in elderly individuals. 35 Tasks include sitting to standing, standing unsupported, transfers, turning, and stepping. Each item is scored from 0 to 4, and the total score ranges from 0 to 56. A score between 0-20 indicates high fall risk and need for assistive devices; 21-40 indicates moderate fall risk; and 41-56 indicates low fall risk with no need for assistive devices.
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 30 Apr 2025.
- Individual participant dataSharing planned: Yes. De-identified data (i-TUG, TUG, and BBS scores) will be available upon request after publication for research purposes.
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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?
An observational study of Stroke, Ischemic and Balance Assessment, run by Istanbul University - Cerrahpasa 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 1 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: finished, as of the sponsor's last update on 30 Apr 2025. 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?
Instrumental Timed Up and Go Test (i-TUG) by EncephaLog (time frame: Day 1 and Day 7). 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 30 Apr 2025.