Balance ControlNCT06758063
Impact of Physical Activities on Balance in Patient With Strabismic Amblyopia
A study testing exercises therapy in people with Balance Control, run by Amany Refaat Mohamed Abdel Wahid at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Balance Control
- What is being tested?
- exercises therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- - 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy Cairo University
Giza, Giza Governorate, 11432
About this study
Official title: 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.
Read the 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.
- Conditions
- Balance Control
- Being tested
- exercises therapy
- Keywords
- Balance, stabismus, amblyopia, physical therapy, exercises
- Medical subject headings
- Amblyopia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercises therapyOther
exercises to improve balance of the body
| Study group | Role | What they receive |
|---|---|---|
| exercise therapy | Other | this group will apply balance exercises two times a week for three months Receives: Other: exercises therapy |
| traditional eye care | No intervention | This group will receive traditional eye observation post strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Berg Balance Scale
- 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
Measured: From enrollment to the end of treatment at 12 weeks
Dynamic single leg stance test
- The subject begins in quiet standing with hands on the hips.
- The subject lifts one leg off the ground and stands unassisted.
- Time starts when the foot is lifted off the ground
- 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.
- Dynamic posture tasks will applied during the test
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Sep 2024
- Primary completion30 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance ControlStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amany Refaat Mohamed Abdel Wahid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Refaat Mohamed Abdel Wahid, Cairo University
- Investigators
- Amany R M Abdel Wahid, Doctoral degree, Principal investigator, Lecturer at faculty of physical therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758063
- Sponsor's protocol ID
- P.T.R/012/005408
- Status last verified
- Apr 2025
- First submitted
- 26 Dec 2024
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Activities on Balance in Patient With Post-surgical Strabismic Amblyopia
- ClinicalTrials.gov ID
- NCT06758063
- Acronym / sponsor ID
- P.T.R/012/005408
- Conditions
- Balance Control
- Keywords
- Balance, stabismus, amblyopia, physical therapy, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amany Refaat Mohamed Abdel WahidUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 3 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise therapy | Other | Other: exercises therapythis group will apply balance exercises two times a week for three months |
| traditional eye care | No intervention | –This group will receive traditional eye observation post strabismus surgery |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- - 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
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 |
|---|---|---|
| exercises therapyexercises to improve balance of the body | Other | exercise therapy |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 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. This study is not recruiting at the moment.
Amany R M Abdel Wahid, Doctoral degree principal investigator
Lecturer at faculty of physical therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises therapy in people with Balance Control, run by Amany Refaat Mohamed Abdel Wahid at 1 site in Egypt.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Berg Balance Scale (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. 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 20 Apr 2025.