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临床试验/NCT07047300
NCT07047300招募中不适用

Effect of Heel Lift Insole on Kinematics and Kinetics of the Lower Limb and Lumbar Spine Among Healthy Individuals

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Muscle activity (Maximum amplitude in microvolt) - Electromyography Device Using interference pattern

研究概览

简要总结

This observational study aims to investigate the effect of heel lift insole on kinematics and kinetics of the lower limb and lumbar spine among healthy individuals.

详细描述

This clinical trial will be conducted among physiotherapy students at Misr University for Science and Technology. Participants will be recruited based on predefined inclusion criteria, and informed consent will be obtained prior to their involvement. Once enrolled, each participant will complete a standardized demographic questionnaire and undergo height and weight measurements to calculate their Body Mass Index (BMI). Those with BMI values outside the normal range, as defined by Shrestha et al. (2023), will be excluded to reduce confounding factors.

Before testing begins, participants will be familiarized with all equipment and procedures. Electromyographic (EMG) data will then be collected to measure maximum muscle activity in the bilateral erector spinae, rectus femoris, and both medial and lateral gastrocnemius muscles. EMG measurements will be taken under two conditions: first, while standing in standardized flat shoes, and second, while wearing a standardized heel lift insole inside the same shoes. Three trials will be performed in each condition, and the mean amplitude will be used for analysis.

In addition to EMG, kinematic data will be assessed using Kinovea software. Photographs will be captured from anterior and lateral views to evaluate each participant's Q angle and lumbosacral angle. As with EMG, these measurements will be repeated under both footwear conditions (flat shoes alone and flat shoes with heel lift insoles), and the results will be compared.

All procedures will follow standardized protocols to ensure consistency and reliability. The primary outcome measure is muscle activity (maximum EMG amplitude), while secondary outcomes include changes in the Q-angle and lumbosacral angle. The study aims to evaluate the impact of heel lift insoles on lower limb muscle activity and postural alignment in healthy individuals.

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 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult non-athletic individuals with age range between (18: 25) years old (Joshi et al., 2024).
  • Height between (160 - 180 cm).
  • Body mass index between (18.5:24.99) Kg/ m² (Joshi et al., 2024).
  • Foot length between (23,3 - 28.0 cm).
  • Never used heel lift insole.
  • Participants must have a normal and pain-free range of motion in the lower limbs and spine (Hapsari et al., 2016).
  • Participants must demonstrate stable balance and coordination in weight-bearing activities (Hapsari et al., 2016).

排除标准

  • Traumatic conditions of the lower limb (Joshi et al., 2024).
  • Pelvis and lower limb musculoskeletal disorders (Joshi et al., 2024).
  • Previous orthopedic disorders or neurological deficit of the lower limb (Joshi et al., 2024).
  • Previous surgery of the lower limbs (Lindenberg et al., 2019).
  • Any sensory problems.
  • Neuromuscular diseases such as multiple sclerosis, intervertebral disc disorders...etc (Joshi et al., 2024).
  • Pregnancy.
  • Cancer Patients.
  • Immunodeficiency diseases.
  • Psychological disorders (depression - anxiety).
  • Chronic diseases as (diabetes - hypertension).
  • Participants with lower limbs deformity (Joshi et al., 2024).
  • Participants with specific lower limb muscles weakness.
  • Low back pain in the past 30 days (Colonna et al., 2024).

结局指标

主要结局

Muscle activity (Maximum amplitude in microvolt) - Electromyography Device Using interference pattern

时间窗: 3 Months

次要结局

  • Q-Angle using objective Kinovea 2D software(3 months)
  • Lumbo-Sacral Angle using objective Kinovea 2D software(3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelrahman Salah Sawan

Teaching assistant

Cairo University

研究点 (2)

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