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临床试验/NCT07830589
NCT07830589进行中(未招募)不适用

Effects of Whole-body Vibration Exercises on Postural Stability in Painful Women With Hypermobility Spectrum Disorders: A Randomized Controlled Trial

Gökalp Arif Utkugün1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Change From Baseline in Posterolateral Reach Score of the Star Excursion Balance Test at 6 Weeks

研究概览

简要总结

This randomized controlled trial aims to investigate the effects of adding whole-body vibration training to a conventional exercise program on postural stability and pain in painful women with hypermobility spectrum disorder. Participants are randomly allocated to conventional exercise or conventional exercise plus whole-body vibration groups and complete a 6-week supervised intervention program.

详细描述

Participants were randomly allocated to two groups. One group received a conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, while the other group received the same conventional exercise program combined with whole-body vibration exercises. Both groups participated in the exercise program for six weeks. All exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician. Participants were evaluated before and after the six-week intervention by a blinded outcome assessor who was unaware of the participants' group allocation.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of hypermobility spectrum disorder (Beighton score ≥4/9) Female participants aged 18-45 years Presence of musculoskeletal pain for at least 3 months

排除标准

  • Pregnancy Presence of a cardiac pacemaker Presence of an implanted brain stimulator Presence of a metal implant Acute or chronic arthritis Active malignancy Acute infection Initiation of medications that may affect proprioception or postural stability (e.g., antidepressants, antipsychotics, or hypnotics) within the previous 2 months Regular exercise more than 3 days per week Postmenopausal status Orthopedic surgery within the previous 12 months Vertigo Acute painful conditions that would prevent participation in exercise

研究组 & 干预措施

Conventional Exercise Group

Active Comparator

Participants allocated to this arm received a supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician.

干预措施: Conventional Exercise Program (Other)

Conventional Exercise Plus Whole-Body Vibration Group

Experimental

Participants allocated to this arm received the same supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, with the addition of whole-body vibration exercises. The intervention was continued for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician.

干预措施: Conventional Exercise Program (Other)

Conventional Exercise Plus Whole-Body Vibration Group

Experimental

Participants allocated to this arm received the same supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, with the addition of whole-body vibration exercises. The intervention was continued for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician.

干预措施: Whole-Body Vibration (Device)

结局指标

主要结局

Change From Baseline in Posterolateral Reach Score of the Star Excursion Balance Test at 6 Weeks

时间窗: Baseline and immediately after the 6-week intervention

Dynamic postural stability was assessed using the Star Excursion Balance Test (SEBT). The posterolateral reach score was calculated by normalizing the maximum posterolateral reach distance to lower-limb length and expressing the value as a percentage. Higher scores indicate better dynamic postural stability. The change from baseline to the end of the 6-week intervention was evaluated.

次要结局

未报告次要终点

研究者

发起方
Gökalp Arif Utkugün
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gökalp Arif Utkugün

Physical Medicine and Rehabilitation Resident

Koç University

研究点 (1)

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