- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06762067
Exercise Training on a Mirror for Intermittent Exotropia Control Post Strabismus Surgery
January 4, 2025 updated by: Nesma Nawwar Abdallah KHattab, Cairo University
Exercise Training in Front of a Mirror for Intermittent Exotropia Control Post Strabismus Surgery: A Randomized Controlled Study
The study aims to explore the impact of mirror therapy on exodeviation control, near and far strabismus angles, and quality of life in intermittent exotropia control post strabismus surgery, as well as its effects on near and far strabismus angles.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Strabismus is a common childhood disorder causing eye deviation, affecting life quality and cosmetic appearance.
Early detection and management improve binocular function and psychosocial problems.
Intermittent exotropia is a common type.
Surgery is the most common method for correcting strabismus, but complications can be difficult to treat.
Physical therapy programs are limited in treating strabismus after surgery, and adding mirror therapy to traditional treatments may help maintain surgery results.
This thesis aims to decrease this knowledge gap and improve the treatment of strabismus.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nesma Nawwar Abdallah khattab, physical therapist
- Phone Number: 01286914661
- Email: nesma.khattab2020@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 40 boys and girls with ages from 5 to 15 years
- History of strabismus surgery from 6 months presence of intermittent exotropia.
- Normal sensory and motor fusion, equal visual acuity. Good general health condition.
- Ability to understand and do the exercises at home
Exclusion Criteria:
- systemic diseases as myasthenia gravis, multiple sclerosis and diabetes
- Optic nerve injury, organic ocular disease, attention disorder and mental disorders
- Attention disorder and learning disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mirror therapy
It will include 20 patients.
They will receive traditional physical therapy exercise using mirror therapy twice a week ,for 3 months ,and subjects will do the same exercise at home daily with the aid of mother and level of adherence will be checked every session
|
Participants will undergo physiotherapy exercises in a mirror alongside post-surgery care.
The program includes palming exercises, eye exercises, pencil push-ups, Brock string exercises, thumb exercises, and proprioceptive neuromuscular facilitation exercises.
The first exercise warms up extra ocular muscles, the second improves eye coordination, the third motivates the lazy eye, the fourth strengthens eye muscles, and the fifth involves a near-distance jump for oblique muscles.
|
|
Active Comparator: Traditional therapy
It will include 20 patients.
They will receive traditional physical therapy exercise only twice a week ,for 3 months ,and subjects will do the same exercise at home daily with the aid of mother and level of adherence will be checked every session
|
The patients within the control group will receive traditional care post-strabismus operation as eye glasses and eye drops and regular exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of change of the exodeviation control
Time Frame: at baseline and after 3 months
|
The ophthalmologist examines participants' eyes while focusing on an accommodative target, determining their exotropia score.
The scores range from constant to dissociated, with no exotropia unless dissociated and maximum score is 5 and minimal score is 0. the lower score is the better
|
at baseline and after 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of change of the near strabismus angles
Time Frame: at baseline and after 3 months
|
the near strabismus angles will be measured by using prisms of different powers
|
at baseline and after 3 months
|
|
Assessment of change of the far strabismus angles
Time Frame: at baseline and after 3 months
|
The prism cover test is a method used to measure the angle of deviation of a small-angle tropia.
It involves covering the non-fixating eye with a prism oriented in the same direction as the deviation, blocking the fixating eye simultaneously.
The strength of the prism is adjusted to prevent fixation shift and reduce deviation.
Near and far strabismus angles are measured using prisms of varying powers.
The measurement should be taken at 33 cm, 6 m, and occasionally at 60 m, and with or without corrective lenses.
|
at baseline and after 3 months
|
|
Assessment of change of questions of Child and Proxy health related quality of life
Time Frame: at baseline and after 3 months
|
The final Child and Proxy health-related quality of life questionnaires for intermittent exotropia are designed to gather information about the concerns and difficulties faced by children and adolescents with this condition.
The questionnaires are formatted for 5-7-year-old children, 8-17-year-old children, and PROXY children.
|
at baseline and after 3 months
|
|
Assessment of change of questions of health-related quality of life questionnaire for Parents of children with intermittent exotropia
Time Frame: at baseline and after 3 months
|
Parents of children with intermittent exotropia often express concerns about their child's eyesight, including potential physical and psychological effects.
|
at baseline and after 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2025
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
December 23, 2024
First Submitted That Met QC Criteria
January 4, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 4, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nesma-005418
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Strabismus
-
Sohag UniversityCompleted
-
Uludag UniversityCompleted
-
University of MiamiCompletedSuture Strabismus SurgeryUnited States
-
Assiut UniversityNot yet recruitingLarge Angle Horizontal StrabismusEgypt
-
Henan Provincial People's HospitalNot yet recruitingStrabismus Surgery
-
Assiut UniversityNot yet recruitingStrabismus Surgery
-
Universidad Autonoma de MadridActive, not recruiting
-
Amany Refaat Mohamed Abdel WahidCompletedStrabismus; IntermittentEgypt
-
Universitat Politècnica de CatalunyaHospital Universitari Mútua de TerrassaNot yet recruitingExotropia Intermittent | Intermittent Strabismus | Esotropia Intermittent
Clinical Trials on mirror therapy
-
The Hong Kong Polytechnic UniversityNational University, Singapore; University of CanterburyNot yet recruiting
-
Olga Del Pozo BlancoHospital Universitario La Fe; University Rovira i VirgiliCompletedCarpal Tunnel SyndromeSpain
-
The Hong Kong Polytechnic UniversityRecruiting
-
Istanbul Medipol University HospitalCompleted
-
Asia UniversityEnrolling by invitationStroke | Hemiparesis After StrokeTaiwan
-
Başakşehir Çam & Sakura City HospitalCompletedStroke | Complex Regional Pain Syndrome I (CRPS I) | Mirror TherapyTurkey (Türkiye)
-
The Hong Kong Polytechnic UniversityTung Wah Hospital; Guangdong 999 Brain HospitalCompletedThe Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke
-
CEU San Pablo UniversityCompleted
-
Universitat Internacional de CatalunyaEnrolling by invitationHemiplegic Cerebral Palsy | Mirror Movement TherapySpain
-
Seoul National University HospitalSeoul National UniversityCompleted