"Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency: A Blind Randomized Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- General mobility
研究概览
简要总结
The aim of this study is to investigate the effect of oculomotor therapy in individuals with ocular convergence insufficiency.
详细描述
Seventy participants with convergence insufficiency (CI) will be randomly allocated into two groups: Experimental Group (EG) (n=35) and Control Group (CG) (n=35). The primary outcome will be CI assessed by the convergence test. Secondary outcomes will include quality of life, postural balance, and gait speed. The EG will undergo five sessions of oculomotor therapy (once a week), based on and adapted from the established protocol for CI treatment. Results: Outcomes will be assessed by blinded evaluators at baseline, one week after the end of the treatment, and at 1 and 3 months follow-up. The CG will not receive any intervention. Data will be analyzed using statistical tests with a significance level set at p < 0.05.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with convergence insufficiency (CI);
- •Aged between 18 and 60 years;
- •Physically active individuals;
- •Without cognitive impairments;
- •Without vestibular system impairments (e.g., dizziness).
排除标准
- •Diagnosis of neurodegenerative diseases (e.g., Parkinson's, ALS);
- •Presence of dementia;
- •History of stroke;
- •Presence of vestibular disorders;
- •Systemic neuromuscular diseases;
- •Disabling musculoskeletal pain;
- •Diagnosis of diabetic polyneuropathy;
- •Use of joint prostheses;
- •Ongoing physical therapy treatment;
- •Lack of physical ability to perform the prescribed physical activities.
结局指标
主要结局
General mobility
时间窗: 3 months
General mobility will be assessed using the Timed 'Up-and-Go' test with time measured in seconds as the unit of measurement.
次要结局
- Single-Leg Stance Test(3 months)
- Postural Control Assessment(3 months)
研究者
Fabiano Politti
Principal Investigator
University of Nove de Julho