Cerebral Palsy (CP)NCT07438223
Effect Of Brain Gym Exercises On Balance And Quality Of Life In Children With Spastic Diplegia
A study testing Brain gym exercises and Conventional physical therapy program in people with Cerebral Palsy (CP) and Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial summary
Statement of the problem Do brain gym exercises affect balance and quality of life in children with spastic diplegia? Null hypotheses: 1. There will be no significant effect of brain gym exercises on balance in children with spastic diplegia. 2. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Cerebral Palsy (CP), Spastic Diplegia
- What is being tested?
- Brain gym exercises and Conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Sep 2026
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 - Children with spastic diplegia who have balance problems in standing and gait.
- 2-Degree of spasticity ranges from 1 and 1+, according to modified Ashworth scale (MAS) .
- 3- The age of children will range from 6 to 8 years old. 4-The height of children will be at least one meter. 5- Children are levels I and II according to GMFCS (Gross Motor Classification System ).
Who cannot join
- Children with visual or auditory problems.
- Children with intellectual disability.
- Children have been injected with Botox injection or have done surgery in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy cairo university
Cairo, Faculty of Physical Therapy
About this study
Statement of the problem Do brain gym exercises affect balance and quality of life in children with spastic diplegia?
Null hypotheses:
- There will be no significant effect of brain gym exercises on balance in children with spastic diplegia.
- There will be no significant effect of brain gym exercises on quality of life in children with spastic diplegia.
Read the detailed description
The Study targets the children with spastic diplegia from both sexes , sample size estimation is 44 children. Children participating in this study will be selected randomly from the pediatric outpatient clinic of Faculty of Physical Therapy Cairo University.
- Conditions
- Cerebral Palsy (CP), Spastic Diplegia
- Being tested
- Brain gym exercises, Conventional physical therapy program
- Keywords
- Brain gym exercises, Cerebral palsy, Diplegia, Balance, Quality of life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain gym exercisesOther
Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midline movements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump
Conventional physical therapy programOther
Conventional physical therapy program includes: Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midlinemovements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump
| Study group | Role | What they receive |
|---|---|---|
| group A will take conventional physical therapy and brain gym exercises | Experimental | Group A will take conventional physical therapy for 45 minutes and brain gym exercises for 30 minutes for three months three sessions per week .
Conventional physical therapy program includes:
Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing
Brain gym exercises include:
Energy exercise:
Drinking water Brain buttons
Midlinemovements:
Cross crawl Lazy eight Belly breathing exercise
Deepening attitude:
Hook- ups
Lengthening activities:
Arm activation The owl
Calf pump Receives: Other: Brain gym exercises; Other: Conventional physical therapy program |
| Group B the control group will take only conventional physical therapy | Experimental | will take the same conventional physical therapy program for 45 minutes three times per week for three months. Receives: Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance
Biodex balance system will measure the overall stability index, antero -posterior stability index and medio- lateral stability index, higher score indicate lower stability.
Measured: 3 months
Cerebral palsy Quality of life
Cerebral Palsy Quality Of Life Questionnaire (CPQOL)contains 66 items each uses a 9- point rating scale ( for items The minimum value 1, maximum value 9)and then transformed to a 0 to 100 scale. As the total score approaches 100 this means better quality of life. The domains evaluated using it are social well being and acceptance, emotional well-being, function and participation and physical health, access to services, pain and impact of disability, and family health..
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Dec 2025
- Primary completion1 Jun 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Mohamed Awaad, Cairo University
- Investigators
- Hagar Mohamed Awaad, Assistant lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438223
- Sponsor's protocol ID
- P.T.REC\012\006105
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Brain Gym Exercises On Balance And Quality Of Life In Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT07438223
- Acronym / sponsor ID
- P.T.REC\012\006105
- Conditions
- Cerebral Palsy (CP), Spastic Diplegia
- Keywords
- Brain gym exercises, Cerebral palsy, Diplegia, Balance, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 27 Feb 2026 (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.
Statement of the problem Do brain gym exercises affect balance and quality of life in children with spastic diplegia?
Null hypotheses:
- There will be no significant effect of brain gym exercises on balance in children with spastic diplegia.
- There will be no significant effect of brain gym exercises on quality of life in children with spastic diplegia.
Detailed description
The Study targets the children with spastic diplegia from both sexes , sample size estimation is 44 children. Children participating in this study will be selected randomly from the pediatric outpatient clinic of Faculty of Physical Therapy Cairo University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A will take conventional physical therapy and brain gym exercises | Experimental | Other: Brain gym exercises, Other: Conventional physical therapy programGroup A will take conventional physical therapy for 45 minutes and brain gym exercises for 30 minutes for three months three sessions per week . Conventional physical therapy program includes: Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midlinemovements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump |
| Group B the control group will take only conventional physical therapy | Experimental | Other: Conventional physical therapy programwill take the same conventional physical therapy program for 45 minutes three times per week for three months. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1 - Children with spastic diplegia who have balance problems in standing and gait.
- 2-Degree of spasticity ranges from 1 and 1+, according to modified Ashworth scale (MAS) .
- 3- The age of children will range from 6 to 8 years old. 4-The height of children will be at least one meter. 5- Children are levels I and II according to GMFCS (Gross Motor Classification System ).
Key exclusion criteria (3 listed)
- Children with visual or auditory problems.
- Children with intellectual disability.
- Children have been injected with Botox injection or have done surgery in the last 6 months.
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 |
|---|---|---|
| Brain gym exercisesBrain gym exercises include: Energy exercise: Drinking water Brain buttons Midline movements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump | Other | group A will take conventional physical therapy and brain gym exercises |
| Conventional physical therapy programConventional physical therapy program includes: Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midlinemovements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump | Other | Group B the control group will take only conventional physical therapy, group A will take conventional physical therapy and brain gym exercises |
Primary outcome
Dynamic balance
Time frame: 3 months
Biodex balance system will measure the overall stability index, antero -posterior stability index and medio- lateral stability index, higher score indicate lower stability.
Cerebral palsy Quality of life
Time frame: 3 months
Cerebral Palsy Quality Of Life Questionnaire (CPQOL)contains 66 items each uses a 9- point rating scale ( for items The minimum value 1, maximum value 9)and then transformed to a 0 to 100 scale. As the total score approaches 100 this means better quality of life. The domains evaluated using it are social well being and acceptance, emotional well-being, function and participation and physical health, access to services, pain and impact of disability, and family health..
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 21 Oct 2026.
Related trials for Cerebral Palsy (CP)
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
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.
Hagar Mohamed Awaad, Assistant lecturer principal investigator
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 Brain gym exercises and Conventional physical therapy program in people with Cerebral Palsy (CP) and Spastic Diplegia, run by Cairo University 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 3 inclusion and 3 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 21 Oct 2026. 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?
Dynamic balance (time frame: 3 months). 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 21 Oct 2026.