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临床试验/NCT06950554
NCT06950554已完成不适用

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

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Instrumental Timed Up and Go Test (i-TUG) by EncephaLog

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Days 至 75 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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.

结局指标

主要结局

Instrumental Timed Up and Go Test (i-TUG) by EncephaLog

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve SEVINC GUNDUZ

RESEARCH ASSISTANT

Bezmialem Vakif University

研究点 (1)

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