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Not yet recruitingNCT06762067Updated Jan 7, 2025

Exercise Training on a Mirror for Intermittent Exotropia Control Post Strabismus Surgery

An interventional study of mirror therapy and traditional therapy in Exercise Training, Intermittent Exotropia and Strabismus, sponsored by Cairo University. Not yet recruiting. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
5 Years to 15 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Exercise Training
  • Intermittent Exotropia
  • Strabismus

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03

In context

Strabismus

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 82 interventional studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 40 boys and girls with ages from 5 to 15 years
  2. History of strabismus surgery from 6 months presence of intermittent exotropia.
  3. Normal sensory and motor fusion, equal visual acuity. Good general health condition.
  4. Ability to understand and do the exercises at home

Exclusion criteria

Exclusion Criteria:

  1. systemic diseases as myasthenia gravis, multiple sclerosis and diabetes
  2. Optic nerve injury, organic ocular disease, attention disorder and mental disorders
  3. Attention disorder and learning disability
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • 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

    Other: mirror therapy

  • 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

    Other: traditional therapy

Interventions

  • Othermirror therapy

    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.

  • Othertraditional therapy

    The patients within the control group will receive traditional care post-strabismus operation as eye glasses and eye drops and regular exercise

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at baseline and after 3 months

Secondary outcomes

  1. Assessment of change of the near strabismus angles

    the near strabismus angles will be measured by using prisms of different powers

    Time frame: at baseline and after 3 months

  2. 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.

    Time frame: at baseline and after 3 months

  3. 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.

    Time frame: at baseline and after 3 months

  4. 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.

    Time frame: at baseline and after 3 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Apr 2025, 2 months later.

Of 35 non-industry interventional studies with no phase under Strabismus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's planned 2 months is below that.

Counting every sponsor, half of 35 studies reached it within 17 months; a quarter within 8 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2024
First posted
Jan 7, 2025
StartEst.
Feb 1, 2025
Primary completionEst.
Apr 1, 2025
CompletionEst.
May 1, 2025
Last update
Jan 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06762067
Lead sponsor
Cairo University
Responsible party
Nesma Nawwar Abdallah KHattab (principal investigator, Cairo University) — Principal investigator
First posted
Jan 7, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Jan 7, 2025

Study contacts

Nesma Nawwar Abdallah khattab, physical therapist
Contact
nesma.khattab2020@gmail.com
01286914661

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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