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临床试验/NCT05303779
NCT05303779已完成不适用

Exercise Interventions of Eye Muscles for Improving Eye Control Post Strabismus Surgery

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
changing in eye control

研究概览

简要总结

The purpose of this study will be focused on the following issue:

  1. The aim of this study is to determine therapeutic effect of postoperative eye exercises on improving eye control after the strabismus surgery.

HYPOTHESES:

It will be hypothesized that:

• Eye exercises have a positive effect on improving eye control post strabismus surgery.

RESEARCH QUESTION:"

• Do postoperative eye exercises improve eye control post strabismus surgery?

详细描述

Therapeutic procedures:

  • Patient will be informed about measurement and treatment procedure before beginning of the treatment.
  • Patient 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.
  • They will start the treatment program after 2 weeks of the surgery.

The subjects will be divided into two groups (experimental group and control group) with equal numbers of patients in each group:

Control group Participants within the control group will receive traditional care and medication following strabismus surgery.

Experimental group Participants within the experimental group will receive physiotherapy exercises beside traditional care and medication after strabismus surgery. Physical therapy exercises will apply in the office and home. Office exercises will involve palming exercise, pencil push-ups, brock string exercise, thumb exercise (Near-distance jump), balance board exercise, Proprioceptors Neuromuscular Facilitating (PNF) exercise, occlusive therapy, eye hand coordination and computer therapy. Office exercises will be done two sessions per week for three months. Each session will be about 1 hour. Exercises will also perform at home from the first session including eye exercises in all directions, pencil push-ups, thumb exercise (Near-distance jump),brock string exercise, and dominant eye occlusion for 1 hour daily.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Criteria of selecting the patients include the following:
  • Patients are both males and females.
  • Their age will range from (5-15) years.
  • Patients received strabismus operation.
  • They will be selected from Outpatient Clinic of Research Institute of Ophthalmology.
  • Patients will begin the training program after 2 weeks of operation.
  • All types of strabismus surgery will be included.

排除标准

  • The subjects will be excluded from the study if they meet one of the following criteria;
  • Muscular disorders that will impair performance during training.
  • Any organic lesion in the eye.
  • Neurological disorders.
  • Malignant conditions.
  • Psychiatric illness, severe behavior or cognitive disorders.
  • Children who can't understand the therapist's instructions and orders.

研究组 & 干预措施

experimental group

Experimental

experimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery

干预措施: Exercise Interventions of Eye Muscles (Other)

experimental group

Experimental

experimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery

干预措施: Medication and eye glasses (Drug)

control group

Active Comparator

control group will receive medication and eye glasses post strabismus surgery

干预措施: Medication and eye glasses (Drug)

结局指标

主要结局

changing in eye control

时间窗: before the treatment and after 12 weeks (at the end of the treatment period )

The level of control will be evaluated in each patient at both distance and near fixation using Intermittent Exotropia Control Scale. Fixation targets will be at 3 meters for distance fixation and it will be at 33 centimeters for near fixation. Intermittent Exotropia Control Scale 5 = Constant exotropia 4 = Exotropia \> 50% of the exam before dissociation 3 = Exotropia \< 50% of the exam before dissociation 2 = No exotropia unless dissociated, recovers in \> 5 seconds 1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in \< 1 second (phoria) The scale ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amany Refaat Mohamed Abdel Wahid

principle investigator

Cairo University

研究点 (1)

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