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临床试验/NCT02728713
NCT02728713已完成不适用

Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

Nova Southeastern University1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2003年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Local Stereoacuity Testing

研究概览

简要总结

The purpose of this study is to determine if there is a measurable change in visual function as a direct result of the application of osteopathic cranial manipulative medicine. The study will also attempt to determine whether any changes noted remain after withdrawal of the treatment.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •free of active ocular or systemic disease
  • •refractive error between six diopters of myopia and five diopters of hyperopia with regular astigmatism of any amount
  • •normal best-corrected visual acuity at 20/40 or better
  • •normal amplitude of accommodation
  • •willing to undergo osteopathic cranial manipulative medicine

排除标准

  • •pregnancy
  • •history of previous closed head trauma or brain injury
  • •prior cranial manipulative treatment/craniosacral therapy
  • •students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry

研究组 & 干预措施

Sham/placebo

Sham Comparator

Assessment for cranial strain patterns, followed a laying on of hands, followed by reassessment. Repeated for a total of eight visits no less than one week apart.

干预措施: Sham/Placebo (Procedure)

Cranial manipulation

Experimental

Assessment for cranial strain patterns, followed by indirect cranial manipulation to treat dysfunctions found on assessment, followed by reassessment.

Repeated for a total of eight visits no less than one week apart.

干预措施: Cranial Manipulation (Procedure)

结局指标

主要结局

Local Stereoacuity Testing

时间窗: Weekly for 16 weeks

Measured by Random Dot E test.

Pupillary Size Testing

时间窗: Weekly for 16 weeks

Measurement of pupil size (each eye) in bright and dim light.

Vergence System Testing

时间窗: Weekly for 16 weeks

Assessed by Cover Test with Prism Neutralization and Near Point of Convergence

Distance Visual Acuity

时间窗: Weekly for 16 weeks

Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart.

Accommodative System Testing

时间窗: Weekly for 16 weeks

Accommodative amplitude testing using a Donder push-up card.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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