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临床试验/NCT02794194
NCT02794194已完成不适用

Effects of a Whole Body Vibration Training on Unstable Surface in Recreational Athletes With Chronic Ankle Instability

University of Castilla-La Mancha2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年12月1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
50
试验地点
2
主要终点
Change in balance (Biodex Balance System test)

研究概览

简要总结

After an initial ankle sprain, Chronic Ankle Instability is one of the most common residual symptoms which include pain, swelling, recurrent sprain, episodes of ankle joint "giving away" or decreased function. Recently, Whole Body Vibration (WBV) training has been introduced as a preventive and rehabilitative tool. It can be hypothesized that WBV on unstable surfaces might enhance neuromuscular control. Therefore, the aim of this study was to investigate the effects of a 6-week WBV training on an unstable surface on body composition, balance, strength and reflex and muscle activity of ankle muscles in recreational athletes with CAI.

详细描述

Participants:

Fifty physically active recreational athletes with self-reported CAI volunteered to participate in the study. These subjects were assigned to one of three groups: the Vibration group (VIB), Non-Vibration group (N-VIB) and Control group (CON).

Each participant was informed of the risks and discomforts associated with this investigation and signed an informed consent document before the onset of the experiments. The experimental protocol was approved by the Ethics Committee of Clinical Research at the Hospital Complex in Toledo (Spain).

Procedures:

The investigators performed a randomized clinical trial with a cross over design. Participants were assessed at three time points: pre-training (Pre), post-training 1 (Post1) and post-training 2 (Post2) (6 weeks after the last training session). Measurements consisted in a body composition analysis, two balance tests, a forced ankle inversion test and an isokinetic strength test. Assessors and the researcher who performed the statistical analysis were blinded to group allocation. Measurements and the training protocol were developed in the Performance and Sport Rehabilitation Laboratory at the University of Castilla-La Mancha (Toledo, Spain).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of at least 1 significant ankle sprain (the most recent injury must have occurred more than 3 months prior to study enrolment).
  • 2 or more episodes of the ankle giving way in the last 6 months.
  • A score of ≤24 on the Spanish version of the Cumberland Ankle Instability Tool.
  • Age range: 18-30 years.

排除标准

  • History of previous surgeries to the musculoskeletal structures in either lower extremity.
  • History of a fracture in either lower extremity requiring realignment.
  • An acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function, resulting in at least 1 interrupted day of desired physical activity.

结局指标

主要结局

Change in balance (Biodex Balance System test)

时间窗: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

Change in electromyographic activity

时间窗: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

Change in muscle strength

时间窗: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

Change in balance (Star Excursion Balance Test (SEBT)

时间窗: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

次要结局

  • Change in lean mass and fat mass (obtained using the enCORE software (GE Healthcare, v. 13.40)(baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention)
  • Change in bone mineral content and bone mineral density (obtained using the enCORE software (GE Healthcare, v. 13.40)(baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention)

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (2)

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