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临床试验/CTRI/2024/10/075657
CTRI/2024/10/075657尚未招募不适用

Reliability and Validity of Inertial Sensors for Static Balance Assessment in Healthy and Chronic Ankle Instability Individuals

N/A1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
RMS: Root Mean Square (Acceleration)

研究概览

简要总结

Chronic ankle instability (CAI) is a common condition marked by frequent ankle sprains and a sense of instability, which negatively impacts balance during daily activities. While inertial sensors, known for being portable, cost-effective, and easy-to-use alternatives to force plates, are widely used to assess balance in neurological populations, their use in musculoskeletal conditions like CAI is limited. These sensors have been applied to conditions such as Parkinson’s and multiple sclerosis, but there is little research on their reliability and validity in CAI population. This study aims to fill that gap by investigating the test-retest reliability and validity of wearable inertial sensors in CAI individuals, using sensitive kinematic parameters like Root Mean Square (RMS) acceleration, JERK, and mean velocity.

Participants will be enrolled based on the inclusion criteria and then asked to perform (Balance error scoring system) BESS test wearing the sensors on the sacrum and shank. Balance error scoring system is a static balance assessment tool consisting of 3 stance conditions (double leg standing, single leg standing and tandem standing) on 2 surface conditions each (firm and foam surface). Then the balance outcome will first be compared to force plate to validate the sensors, test will be performed again after 24 hrs. to check the reliability.

Outcome measure like Root Mean Square Acceleration, JERK (Rate of change of acceleration) and Mean velocity will be assessed 2 times within 24 hrs. interval. Also, the data will be compared to prokin 252  tecnobody with center of pressure (COP) ellipse area, path length and average velocity for validation of inertial sensors. The data collected by the inertial sensors and prokin 252 will be assessed in MATLAB and SPSS windows version will be used in the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • CAI group: A history of at least one lateral ankle sprain, a history of at least two instances of the affected joint “giving way” or feeling of instability within the past 6 months, Cumberland ankle instability tool (CAIT) score less than 25 Healthy group: Asymptomatic individuals with no laxity and no history of lower extremity or trunk injury that may affect balance.

排除标准

  • Any acute and subacute ankle sprain Any diagnosed neurological or systemic condition which may affect balance Uncorrected hearing or visual impairment.
  • History of spine or lower limb surgery and trauma.
  • No prior history of balance training.

结局指标

主要结局

RMS: Root Mean Square (Acceleration)

时间窗: Day 1 baseline test | Day 2 re test (for reliability)

Jerk: Rate of change of acceleration

时间窗: Day 1 baseline test | Day 2 re test (for reliability)

MV: Mean Velocity

时间窗: Day 1 baseline test | Day 2 re test (for reliability)

COP ellipse area

时间窗: Day 1 baseline test | Day 2 re test (for reliability)

COP path length (total distance)

时间窗: Day 1 baseline test | Day 2 re test (for reliability)

Average COP velocity

时间窗: Day 1 baseline test | Day 2 re test (for reliability)

Standard deviation and Root mean square COP

时间窗: Day 1 baseline test | Day 2 re test (for reliability)

次要结局

  • COP ellipse area(COP path length (total distance))

研究者

发起方
N/A
申办方类型
Other [n/a]
责任方
Principal Investigator
主要研究者

Akshita Lala

Indian Spinal Injuries Center Institute of Rehabilitation Sciences

研究点 (1)

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