Effect of Vergence Exercises for Rehabilitation of Patients With Convergence Insufficiency as a Long-term Consequence of Concussion.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Near point of convergence - week 36
研究概览
简要总结
A large proportion of concussion patients with long-term consequences of concussion experience visually related symptoms such as headache, blurred vision, double vision, and fatigue.
These patients often have difficulties coordinating the movement of the two eyes (convergence insufficiency) which is essential for single and clear vision to be obtained and is hence a likely explanation for the symptoms.
100 patients with long-term symptoms of concussion and convergence insufficiency will be offered either exercises or placebo treatment the evaluate the effect of exercises aimed at improving coordination between the two eyes.
The study will provide data to support clinicians in deciding whether to use exercises or not as a treatment of symptoms for patients with convergence insufficiency as a long-term consequence of concussion.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concussion at least 3 month ago
- •Convergence insufficiency which has not been diagnosed prior to the concussion
排除标准
- •Patient who are unable to fulfill baseline examination
- •Manifest or paralytic strabismus
- •Self-reported eye disease
结局指标
主要结局
Near point of convergence - week 36
时间窗: Duration (2 minutes) and performed at week 36
Psychophysical test of the eyes ability to converge
Positive fusional vergence at 40 cm - week 18
时间窗: Duration (2 minutes) and performed at week 18
Psychophysical test of the slow fusional adaptation
Vergence facility at 40 cm - week 36
时间窗: Duration (2 minutes) and performed at week 36
Psychophysical test of fast fusional adaptation
Convergence Insufficiency Symptom Survey (CISS) week 18
时间窗: Duration (5 minutes) and performed at week 18
Questionnaire assessing the frequency of eye and visually related symptom during near work
Near point of convergence - week 18
时间窗: Duration (2 minutes) and performed at week 18
Psychophysical test of the eyes ability to converge
Convergence Insufficiency Symptom Survey (CISS) week 36
时间窗: Duration (5 minutes) and performed at week 36
Questionnaire assessing the frequency of eye and visually related symptom during near work
Positive fusional vergence at 40 cm - week 36
时间窗: Duration (2 minutes) and performed at week 36
Psychophysical test of the slow fusional adaptation
Vergence facility at 40 cm - week 18
时间窗: Duration (2 minutes) and performed at week 18
Psychophysical test of fast fusional adaptation
次要结局
- Rivermead post-concussional symptoms questionnaire (RPQ) - week 18(Duration (5 minutes) and performed at week 18)
- Rivermead post-concussional symptoms questionnaire (RPQ) - week 36(Duration (5 minutes) and performed at week 36)