Exercise Interventions for Improving Eye Control Post Strabismus Surgery

Strabismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05303779
• Other study ID #: P.T.REC/012/003505
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Strabismus

Intervention

Other:
• Exercise Interventions of Eye Muscles
Application of eye exercise for improving eye control post strabismus surgery

Drug:
• Medication and eye glasses
medication and eye glasses used post strabismus surgery

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )