Clinical trial NCT06950554: Validity and Reliablity of i-TUG Via EncephaLog
Official title: From Clinic to Smartphone: Evaluating the i-TUG for Balance and Fall Risk in Chronic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Balance Assessment
Smartphones
Keywords: Stroke, Balance, Berg balance scale, Rehabilitation, EncephaLog
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ischemic stroke patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Instrumental Timed Up and Go Test (i-TUG) by EncephaLog
timeFrame: Day 1 and Day 7
measure: Timed Up and Go Test (TUG)
timeFrame: Day 1 and Day 7
measure: Berg Balance Scale (BBS)
timeFrame: Day 1 and Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Eyupsultan
Study officials:
References: