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临床试验/NCT07108491
NCT07108491已完成不适用

The Effects of Balance Training With Progressive Intermittent Visual Occlusions on Balance, Instability, Muscle Strength, and Functional Performance in Patients With Chronic Ankle Instability (RCT)

Sahmyook University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年2月24日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
dynamic balance

研究概览

简要总结

Based on the purpose of this study, the following hypotheses were established:

There will be a significant difference in balance changes within and between groups following balance training with progressive intermittent visual occlusions compared to general balance training.

There will be a significant difference in instability changes within and between groups following balance training with progressive intermittent visual occlusions compared to general balance training.

There will be a significant difference in muscle strength changes within and between groups following balance training with progressive intermittent visual occlusions compared to general balance training.

There will be a significant difference in functional performance changes within and between groups following balance training with progressive intermittent visual occlusions compared to general balance training.

详细描述

In this study, participants were voluntarily recruited through social networking services, university bulletin boards, and in-hospital advertisements at N Hospital in Seoul. A total of 28 participants were provided with sufficient information regarding the purpose, procedures, and assessment methods of the study. After obtaining written informed consent, the participants were randomly assigned into either the experimental group (n = 14), which received balance training with progressive intermittent visual occlusions, or the control group (n = 14), which received general balance training only, using the randomization website (www.randomizer.org). Random assignment was conducted in a single-blind manner, and participants were unaware of their group allocation.

During the pre-intervention assessment, general characteristics (sex, side tested, age, height, weight, BMI, leg length) were recorded. Measures of balance, instability, muscle strength, and functional performance were taken. Each variable was measured three times to reduce error, and the average value was calculated.

Interventions were conducted individually in a designated private space, and participants were scheduled according to their availability. The experimental group participated in balance training with progressive intermittent visual occlusions twice a week for four weeks (eight sessions in total), with each session lasting 30 minutes. The control group performed the same balance training protocol without wearing stroboscopic glasses.

All interventions were administered by an experienced physical therapist with more than 10 years of clinical experience. Pre- and post-assessments were conducted by a blinded assessor who was unaware of the participants' group allocation. All procedures before and after the intervention were conducted under the same conditions. Following the intervention, balance, instability, muscle strength, and functional performance were reassessed using the same protocols as in the pretest.

During the intervention period, one participant in the experimental group dropped out due to plantar foot pain, resulting in a final sample size of 13 in the experimental group and 14 in the control group for the statistical analysis.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Stroboscopic Balance Training Group

Experimental

The experimental group performed balance training with stroboscopic glasses twice a week for four weeks

干预措施: Balance Training with Stroboscopic Glasses (Biological)

Control Group (General Balance Training)

Active Comparator

The control group performed the same balance training twice a week for four weeks

干预措施: Balance Training without Glasses (Biological)

结局指标

主要结局

dynamic balance

时间窗: At baseline (pre-intervention) and 4 weeks after completing the intervention

Dynamic balance ability was assessed using the Y-Balance Test. The posterior-medial and posterior-lateral directions were set at 90 degrees to each other, and each was set at 135 degrees relative to the anterior direction. The directions were determined based on the supporting leg. Participants performed three practice trials followed by three test trials for each direction. All measurements were conducted barefoot, and reach distances were measured in centimeters using a measuring tape. Participants stood at the center point where the tape lines intersected and reached as far as possible in the anterior, posterior-medial, and posterior-lateral directions.

Static balance

时间窗: At baseline (pre-intervention) and 4 weeks after completing the intervention

Static balance ability was assessed using the Modified Static Postural Stability Test. Participants stood on one leg with the knee fully extended and maintained a heel-raised position, lifting the heel approximately 2-3 cm off the ground. The measurement was stopped if balance was lost, and the duration of maintaining the position was recorded in seconds.

次要结局

  • instability(At baseline (pre-intervention) and 4 weeks after completing the intervention)
  • muscle strength(At baseline (pre-intervention) and 4 weeks after completing the intervention)
  • function(At baseline (pre-intervention) and 4 weeks after completing the intervention)

研究者

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

Miyong Jeong

Graduate Student Researcher

Sahmyook University

研究点 (1)

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