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临床试验/NCT06583434
NCT06583434已完成不适用

Effects of Stabilization-based Pilates Exercise on Gait and Balance in Women With Flexible Pesplanus

Hyun Ju Kim2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年1月2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
22
试验地点
2
主要终点
Change in step time

研究概览

简要总结

The goal of this clinical trial was to determine if stabilization-based Pilates exercises could improve gait and balance in women with flexible flatfoot.

The main questions it aimed to answer were:

Did Pilates training improve gait parameters in women with flexible flatfoot? Did Pilates training reduce balance instability in these participants?

Researchers compared the Pilates training group to a non-training group. The results showed significant improvements in gait and balance for those who participated in the Pilates training.

Participants:

Completed twice-weekly Pilates sessions for 8 weeks. Underwent pre- and post-intervention assessments of gait and balance.

详细描述

Study object This randomized controlled trial aims to assess the effects of stabilization-based Pilates exercises on gait and balance in women with flexible flatfoot. The study focuses on determining whether a specific Pilates program can provide non-invasive rehabilitation for improving gait patterns and reducing balance instability.

Participants The study will include 22 healthy women with flexible flatfoot who have no congenital deformities or diseases of the feet, knees and have a navicular drop of ≥10 mm. The participants will be recruited from "Clinical Pilates" studio in Busan city. Women with bilateral flatfoot (n=22) will be randomly allocated to either the Pilates training group (PTG, n=11) or the non-training group (NTG, n=11).

Outcome measure gait assessment and data acquisition: Participants undergo several practice walks to familiarize themselves with the gait assessment. Three records are averaged once they show a normal gait pattern. The assessment uses measurements from both legs and is conducted in a non-distracting environment.

Seven 3D infrared motion capture cameras (Vicon camera MX-T20, Oxford Metrics, Oxford, UK) and 16 circular reflective markers (14-mm diameter) are used to acquire the data for the gait assessment. The reflective markers are attached to the anterior superior iliac spine, posterior superior iliac spine, lateral mid-thigh, lateral femoral epicondyle, mid-shin, lateral malleolus, second metatarsus, and heel of both the left and right legs. The height, body weight, and width of knee and ankle joints are measured and entered. Gait analysis includes temporal parameters, such as foot-off, step time, stride time, walking speed, and cadence. Kinematic data are collected using Vicon plug-in gait system (Oxford Metrics) at a sampling frequency of 100 Hz.

balance assessment and data acquisition: The participants are instructed to stand with their arms crossed in front of their chest, with one leg supported and one leg raised with the knee at a 90° angle. Participants hold that standing position for 40 seconds. Three successful attempts are recorded for each participant. Measurements are taken for both legs, and the participants are given sufficient time to rest between each stage of the experiment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Bilateral navicular drop of ≥10 mm

排除标准

  • Clinical diagnosis of Alzheimer's Disease
  • Severe heart conditions (heart failure, myocardial infarction)
  • History of knee, ankle or hip injuries within the last 3 months
  • Chronic lung disease
  • Pregnancy
  • Congenital Foot Deformity ( Polydactyly, Syndactyly)

结局指标

主要结局

Change in step time

时间窗: Baseline and after 8 weeks

Step time was measured in seconds using a 3D motion capture system.

Change in stride time

时间窗: Baseline and after 8 weeks

Stride time was measured in seconds using a 3D motion capture system.

Change in walking speed

时间窗: Baseline and after 8 weeks

Walking speed was measured in meters per second using a 3D motion capture system.

Change in cadence

时间窗: Baseline and after 8 weeks

Cadence was measured in steps per minute using a 3D motion capture system.

Change in foot off

时间窗: Baseline and after 8 weeks

Foot off was measured as a percentage of the gate cycle using a 3D motion capture system.

Change in balance stability

时间窗: Baseline and after 8 weeks

Balance was assessed using a single-leg stance test, measuring the center of pressure(COP) sway in both anterior-posterior (AP) and medial-lateral (ML) directions.

次要结局

未报告次要终点

研究者

发起方
Hyun Ju Kim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hyun Ju Kim

Principal Investigator

Busan University of Foreign Studies

研究点 (2)

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