Exercise Interventions for Improving Eye Control Post Strabismus Surgery

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

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?

Study Overview

• Status: Completed
• Conditions: Strabismus
• Intervention / Treatment: Other: Exercise Interventions of Eye Muscles; Drug: Medication and eye glasses

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group; experimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery	Other: Exercise Interventions of Eye Muscles; Application of eye exercise for improving eye control post strabismus surgery; Other Names: experimental; Drug: Medication and eye glasses; medication and eye glasses used post strabismus surgery; Other Names: control
ACTIVE_COMPARATOR: control group; control group will receive medication and eye glasses post strabismus surgery	Drug: Medication and eye glasses; medication and eye glasses used post strabismus surgery; Other Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changing in eye control	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).	before the treatment and after 12 weeks (at the end of the treatment period )

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Amany Abdel Wahid, PhD, Lecturer

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2022
• Primary Completion (ACTUAL): July 15, 2022
• Study Completion (ACTUAL): August 15, 2022

Study Registration Dates

• First Submitted: February 26, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (ACTUAL): March 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus
• Other Study ID Numbers: P.T.REC/012/003505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No