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Validity and Reliablity of i-TUG Via EncephaLog

From Clinic to Smartphone: Evaluating the i-TUG for Balance and Fall Risk in Chronic Stroke

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06950554
Acronym
EncephaLog
Enrollment
37
Registered
2025-04-30
Start date
2024-11-25
Completion date
2025-04-05
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance Assessment, Smartphones, Stroke, Ischemic

Keywords

Stroke, Balance, Berg balance scale, Rehabilitation, EncephaLog

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.

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.

Interventions

None listed

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Days to 75 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Instrumental Timed Up and Go Test (i-TUG) by EncephaLogDay 1 and Day 7The 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)Day 1 and Day 7The 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)Day 1 and Day 7The 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026