- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06758063
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
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
|
|
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
|
|
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.R/012/005408
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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