Exercise Interventions for Improving Eye Control Post Strabismus Surgery

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05303779

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

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?

Condition or Disease	Intervention/Treatment	Phase
Strabismus	Other: Exercise Interventions of Eye Muscles Drug: Medication and eye glasses	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amany Refaat Mohamed Abdel Wahid, principle investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05303779

Other Study ID Numbers:

P.T.REC/012/003505

First Posted:

Mar 31, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Strabismus

Study Results

No Results Posted as of Mar 31, 2022