Impact of Physical Activities on Balance in Patient With Strabismic Amblyopia

April 18, 2025 updated by: Amany Refaat Mohamed Abdel Wahid

Impact of Physical Activities on Balance in Patient With Post-surgical Strabismic Amblyopia

The aim of this study is to determine the effect of physical activities on balance in patient with amblyopia after strabismus surgery. Patients with strabismus have more difficulty in maintaining postural control in the presence of misleading signals. Through this study the patients will apply physical therapy sessions to improve balance for strabismic amblyopic patient post-surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Patients will be informed about measurement and treatment procedure, also about the effect of physical activity on improving balance post strabismus surgery.
  • Patients 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.
  • The therapeutic group will receive 2 sessions per week for 12 weeks. The duration of each session is 45 min.
  • They will start the treatment program after 2 months of the surgery.

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

      • Giza, Egypt, 11432
        • Faculty of Physical Therapy Cairo University

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:

  • Patients received strabismus operation.
  • Patients are suffering from balance problem due to strabismus
  • Patients are suffering from strabismus amblyopia
  • They will be selected from Outpatient Clinic of Research Institute of Ophthalmology.
  • Patients will begin the training program after 2 months of operation.
  • Patient with intermittent exotropia

Exclusion Criteria:

  • - Patients with a diagnosis of vestibular, neurological and psychiatric diseases
  • Moderate and severe amblyopia,
  • Any disease that can cause imbalance syndrome or limitation of movement
  • A history of falling without a cause in the last 6 months and
  • Using drugs affecting the central nervous system
  • Patient who didn't complete the physiotherapy training program for 3 months.
  • Muscular disorders that will impair performance during training.
  • Any organic lesion in the eye.
  • Malignant conditions.
  • Children who can't understand the therapist's instructions and orders
  • Amblyopia which is not related to strabismus condition

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
Other: exercise therapy
this group will apply balance exercises two times a week for three months
exercises to improve balance of the body
No Intervention: traditional eye care
This group will receive traditional eye observation post strabismus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Berg Balance Scale
Time Frame: From enrollment to the end of treatment at 12 weeks
  • The scale involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided into 3 domains: sitting balance, standing balance, and dynamic balance.
  • Each task is graded on a 5-point ordinal scale that ranges from 0 to 4 for a maximum score of 56. In general, a score of 0 is given when the individual is unable to perform the task, and a score of 4 is given when able to complete the given task independently
From enrollment to the end of treatment at 12 weeks
Dynamic single leg stance test
Time Frame: From enrollment to the end of treatment at 12 weeks
  1. The subject begins in quiet standing with hands on the hips.
  2. The subject lifts one leg off the ground and stands unassisted.
  3. Time starts when the foot is lifted off the ground
  4. Time stops when the lifted foot either makes contact with the ground, makes contact with the stance limb, when the stance foot moves laterally on the floor, or when the hands leave the hips.
  5. Dynamic posture tasks will applied during the test
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amany R M Abdel Wahid, Doctoral degree, Lecturer at faculty of physical therapy, Cairo University

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 (Actual)

September 1, 2024

Primary Completion (Actual)

March 30, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

December 26, 2024

First Posted (Actual)

January 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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