Validity and Reliablity of i-TUG Via EncephaLog

NCT06950554 | Completed

• 1 other identifier: 12.11.2024-171654
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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. Construct validity was analyzed using Pearson correlation coefficients. Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC) values were also calculated.

Conditions

Stroke, Ischemic; Balance Assessment; Smartphones

Keywords

Stroke, Balance, Berg balance scale, Rehabilitation, EncephaLog

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Days - 75 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

ischemic stroke patients

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyupsultan, 34250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESEARCH ASSISTANT

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 30, 2025
• Study Start: November 25, 2024
• Primary Completion: March 5, 2025
• Study Completion: April 5, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• 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.

Locations

TU (1)