Exercise TrainingNCT06762067
Exercise Training on a Mirror for Intermittent Exotropia Control Post Strabismus Surgery
A study testing mirror therapy and traditional therapy in people with Exercise Training and Intermittent Exotropia, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Exercise Training, Intermittent Exotropia, Strabismus
- What is being tested?
- mirror therapy and traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise Training, Intermittent Exotropia, Strabismus
- Being tested
- mirror therapy, traditional therapy
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapyOther
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.
traditional therapyOther
The patients within the control group will receive traditional care post-strabismus operation as eye glasses and eye drops and regular exercise
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy | Experimental | 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 Receives: Other: mirror therapy |
| Traditional therapy | Active comparator | 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 Receives: Other: traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of the exodeviation control
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
Measured: at baseline and after 3 months
Secondary outcomes (4)
Assessment of change of the near strabismus angles
the near strabismus angles will be measured by using prisms of different powers
Measured: at baseline and after 3 months
Assessment of change of the far strabismus angles
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.
Measured: at baseline and after 3 months
Assessment of change of questions of Child and Proxy health related quality of life
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.
Measured: 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
Parents of children with intermittent exotropia often express concerns about their child's eyesight, including potential physical and psychological effects.
Measured: at baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Nawwar Abdallah KHattab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762067
- Sponsor's protocol ID
- Nesma-005418
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in Front of a Mirror for Intermittent Exotropia Control Post Strabismus Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06762067
- Acronym / sponsor ID
- Nesma-005418
- Conditions
- Exercise Training, Intermittent Exotropia, Strabismus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy | Experimental | Other: mirror therapyIt 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 |
| Traditional therapy | Active comparator | Other: traditional therapyIt 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 |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirror therapyParticipants 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. | Other | Mirror therapy |
| traditional therapyThe patients within the control group will receive traditional care post-strabismus operation as eye glasses and eye drops and regular exercise | Other | Traditional therapy |
Primary outcome
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
4 secondary outcomes
Assessment of change of the near strabismus angles
Time frame: at baseline and after 3 months
Assessment of change of the far strabismus angles
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing mirror therapy and traditional therapy in people with Exercise Training and Intermittent Exotropia, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nesma Nawwar Abdallah khattab, physical therapist (01286914661, nesma.khattab2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of the exodeviation control (time frame: at baseline and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.