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临床试验/NCT06758063
NCT06758063已完成不适用

Impact of Physical Activities on Balance in Patient With Post-surgical Strabismic Amblyopia

Amany Refaat Mohamed Abdel Wahid2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
The Berg Balance Scale

研究概览

简要总结

The aim of this study is to determine the effect of physical activities on balance in patient with amblyopia after strabismus surgery. Patients with strabismus have more difficulty in maintaining postural control in the presence of misleading signals. Through this study the patients will apply physical therapy sessions to improve balance for strabismic amblyopic patient post-surgery.

详细描述

  • Patients will be informed about measurement and treatment procedure, also about the effect of physical activity on improving balance post strabismus surgery.
  • Patients will be asked to follow physician instructions.
  • Patients will be asked to avoid participation in any rehabilitation program prior to the study which may affect the result of the study.
  • Measurement procedures will be applied for each patient.
  • The therapeutic group will receive 2 sessions per week for 12 weeks. The duration of each session is 45 min.
  • They will start the treatment program after 2 months of the surgery.

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 (Participant)

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients received strabismus operation.
  • Patients are suffering from balance problem due to strabismus
  • Patients are suffering from strabismus amblyopia
  • They will be selected from Outpatient Clinic of Research Institute of Ophthalmology.
  • Patients will begin the training program after 2 months of operation.
  • Patient with intermittent exotropia

排除标准

  • - Patients with a diagnosis of vestibular, neurological and psychiatric diseases
  • Moderate and severe amblyopia,
  • Any disease that can cause imbalance syndrome or limitation of movement
  • A history of falling without a cause in the last 6 months and
  • Using drugs affecting the central nervous system
  • Patient who didn't complete the physiotherapy training program for 3 months.
  • Muscular disorders that will impair performance during training.
  • Any organic lesion in the eye.
  • Malignant conditions.
  • Children who can't understand the therapist's instructions and orders
  • Amblyopia which is not related to strabismus condition

结局指标

主要结局

The Berg Balance Scale

时间窗: From enrollment to the end of treatment at 12 weeks

* The scale involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided into 3 domains: sitting balance, standing balance, and dynamic balance. * Each task is graded on a 5-point ordinal scale that ranges from 0 to 4 for a maximum score of 56. In general, a score of 0 is given when the individual is unable to perform the task, and a score of 4 is given when able to complete the given task independently

Dynamic single leg stance test

时间窗: From enrollment to the end of treatment at 12 weeks

1. The subject begins in quiet standing with hands on the hips. 2. The subject lifts one leg off the ground and stands unassisted. 3. Time starts when the foot is lifted off the ground 4. Time stops when the lifted foot either makes contact with the ground, makes contact with the stance limb, when the stance foot moves laterally on the floor, or when the hands leave the hips. 5. Dynamic posture tasks will applied during the test

次要结局

未报告次要终点

研究者

发起方
Amany Refaat Mohamed Abdel Wahid
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amany Refaat Mohamed Abdel Wahid

Lecturer at department of Surgery, faculty of Physical Therapy, Cairo University

Cairo University

研究点 (2)

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