NCT06762067

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

December 23, 2024

Last Update Submit

January 4, 2025

Conditions

Outcome Measures

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

    at baseline and after 3 months

Secondary Outcomes (4)

  • Assessment of change of the near strabismus angles

    at baseline and after 3 months

  • Assessment of change of the far strabismus angles

    at baseline and after 3 months

  • Assessment of change of questions of Child and Proxy health related quality of life

    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

    at baseline and after 3 months

Study Arms (2)

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

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

Other: traditional therapy

Interventions

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.

Mirror therapy

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

Traditional therapy

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Strabismus

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Central Study Contacts

Nesma Nawwar Abdallah khattab, physical therapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 7, 2025

Study Start

February 1, 2025

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01