Validity and Reliablity of i-TUG Via EncephaLog (EncephaLog)

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic; Smartphones; Balance Assessment

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 Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Turkey
  • Eyupsultan
    • Istanbul, Eyupsultan, Turkey, 34250
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ischemic stroke patients

Description

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, and the spasticity of the m. gastrocnemius was graded as 2 or less on the Modified Ashworth Scale (MAS).

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 1 and Day 7

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Actual): March 5, 2025
• Study Completion (Actual): April 5, 2025

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Stroke, Balance, Berg balance scale, Rehabilitation, EncephaLog
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: 12.11.2024-171654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data (i-TUG, TUG, and BBS scores) will be available upon request after publication for research purposes.
• IPD Sharing Time Frame: De-identified individual participant data and supporting documents (study protocol, statistical analysis plan, and analytic code) will be available beginning 6 months after publication and will remain available for 2 years.
• IPD Sharing Access Criteria: Qualified researchers affiliated with academic institutions will be able to request access to de-identified individual participant data (i-TUG, TUG, BBS scores), study protocol, statistical analysis plan, and analytic code. Requests should be submitted to the corresponding author and will be reviewed by the study team. Data will be shared via secure institutional data transfer platforms.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No