Exercise Interventions for Improving Eye Control Post Strabismus Surgery

Not Applicable

Completed

• Conditions: Strabismus
• Interventions: Drug: Medication and eye glasses; Other: Exercise Interventions of Eye Muscles

• Registration Number: NCT05303779
• Lead Sponsor: Cairo University

Brief Summary

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?

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-02-26
• Study Start: 2022-03-15
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Primary Completion: 2022-07-15
• Study Completion: 2022-08-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
control group	Medication and eye glasses	control group will receive medication and eye glasses post strabismus surgery
experimental group	Medication and eye glasses	experimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery
experimental group	Exercise Interventions of Eye Muscles	experimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery

Primary Outcome Measures

Name	Time	Method
changing in eye control	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).

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt