Spastic Cerebral PalsyNCT07012122
Effect of Disturbed Attention on Balance in Children With Spastic Cerebral Palsy
An observational study of Spastic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the current study is to determine if there is a correlation between disturbed attention and balance in children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- visual spatial memory task, nonspatial verbal memory task and visuomotor tracking task
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2025to 20 Jul 2025
- Phase
- Observational
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Sixty-three children with diplegic Cerebral Palsy of both genders that will be selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University.
Who may be able to join
- Cerebral palsy children with spastic diplegia.
- Age ranges from 8 -12 years.
- Level Ι - II according to Gross Motor Functional Classification System (GMFCS).
- Grade 1, 1+ of the Modified Ashworth Scale.
Who cannot join
- Children that suffer from epilepsy.
- Severe visual and auditory problems.
- Structural or fixed soft tissue deformities of Lower extremities.
- Severe mental retardation.
- Botox injection in the lower extremity in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the current study is to determine if there is a correlation between disturbed attention and balance in children with spastic diplegia.
Read the detailed description
The neuromuscular impairments in children with cerebral palsy (CP) are manifested in abnormal posture and loss of selective motor control, poor trunk control and balance which contributes to poor postural control with significant limitations in their activities of daily living. Balance and upright postural control are fundamental components of movement which plays a major role in maintaining the body in equilibrium in a given sensory environment, with anticipatory and automatic postural adjustments. So, improving balance abilities in such children is fundamental.
In general, attention involves processes that allow individuals to focus on particular aspects of the environment and to mobilize sufficient effort for learning and problem solving.
Children with diplegic CP encounter difficulties in sensory processing and integration which influence the achievement of mature postural control.
There is reviews that didn't cover the relation between attention and balance. This study is to improve evidence regarding this area.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- visual spatial memory task, nonspatial verbal memory task, visuomotor tracking task
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual spatial memory taskOther
The child will be asked to put numbers in an imagined matrices and memorize the position very well then will be asked to remember the position of these numbers.
nonspatial verbal memory taskOther
The child is presented with a series of sentences that are similar in structure and content, with only slight variations in elements such as the verb, subject, or object. The child's task is to remember and accurately recall these sentences. For example: The dog is running in the park, The cat is running in the park, The dog is playing in the park, The dog is running in the yard.
visuomotor tracking taskOther
Then the rest will be introduced in the form of computer screen in front of the child with a dot moving under the control of a computer mouse and asking the child to track the dot while maintaining his balance as much as he can.
| Study group | Role | What they receive |
|---|---|---|
| Group of visual spatial memory task | It will consist of 21 children, who will perform a visual spatial memory task. Receives: Other: visual spatial memory task | |
| Group of nonspatial verbal memory task | It will consist of 21 children, who will perform a nonspatial verbal memory task. Receives: Other: nonspatial verbal memory task | |
| Group of visuomotor tracking task | It will consist of 21 children, who will perform a visuomotor tracking task. Receives: Other: visuomotor tracking task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall stability index (OSI)
Values for the overall stability index (OSI) will be recorded by the Biodex balance system in the beginning with out any disturbance to the child attention, and then recorded during each task performed within their assigned group. Low OSI value indicates good balance and stability, with minimal sway or movement. High OSI value indicates difficulty maintaining balance and stability, with increased sway or movement, potentially suggesting impaired motor control or balance problems.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start10 Jun 2025
- Primary completion10 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Abd Elnaser Abdelrahman, Cairo University
- Investigators
- Asmaa Osama Sayed, PhD, Study chair, Assistant Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012122
- Sponsor's protocol ID
- P.T.REC/012/003969
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Disturbed Attention on Balance in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07012122
- Acronym / sponsor ID
- P.T.REC/012/003969
- Conditions
- Spastic Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 10 Jun 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 purpose of the current study is to determine if there is a correlation between disturbed attention and balance in children with spastic diplegia.
Detailed description
The neuromuscular impairments in children with cerebral palsy (CP) are manifested in abnormal posture and loss of selective motor control, poor trunk control and balance which contributes to poor postural control with significant limitations in their activities of daily living. Balance and upright postural control are fundamental components of movement which plays a major role in maintaining the body in equilibrium in a given sensory environment, with anticipatory and automatic postural adjustments. So, improving balance abilities in such children is fundamental.
In general, attention involves processes that allow individuals to focus on particular aspects of the environment and to mobilize sufficient effort for learning and problem solving.
Children with diplegic CP encounter difficulties in sensory processing and integration which influence the achievement of mature postural control.
There is reviews that didn't cover the relation between attention and balance. This study is to improve evidence regarding this area.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group of visual spatial memory task | – | Other: visual spatial memory taskIt will consist of 21 children, who will perform a visual spatial memory task. |
| Group of nonspatial verbal memory task | – | Other: nonspatial verbal memory taskIt will consist of 21 children, who will perform a nonspatial verbal memory task. |
| Group of visuomotor tracking task | – | Other: visuomotor tracking taskIt will consist of 21 children, who will perform a visuomotor tracking task. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Sixty-three children with diplegic Cerebral Palsy of both genders that will be selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University.
Key inclusion criteria (4 listed)
- Cerebral palsy children with spastic diplegia.
- Age ranges from 8 -12 years.
- Level Ι - II according to Gross Motor Functional Classification System (GMFCS).
- Grade 1, 1+ of the Modified Ashworth Scale.
Key exclusion criteria (5 listed)
- Children that suffer from epilepsy.
- Severe visual and auditory problems.
- Structural or fixed soft tissue deformities of Lower extremities.
- Severe mental retardation.
- Botox injection in the lower extremity in the past 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 |
|---|---|---|
| visual spatial memory taskThe child will be asked to put numbers in an imagined matrices and memorize the position very well then will be asked to remember the position of these numbers. | Other | Group of visual spatial memory task |
| nonspatial verbal memory taskThe child is presented with a series of sentences that are similar in structure and content, with only slight variations in elements such as the verb, subject, or object. The child's task is to remember and accurately recall these sentences. For example: The dog is running in the park, The cat is running in the park, The dog is playing in the park, The dog is running in the yard. | Other | Group of nonspatial verbal memory task |
| visuomotor tracking taskThen the rest will be introduced in the form of computer screen in front of the child with a dot moving under the control of a computer mouse and asking the child to track the dot while maintaining his balance as much as he can. | Other | Group of visuomotor tracking task |
Primary outcome
Overall stability index (OSI)
Time frame: One hour
Values for the overall stability index (OSI) will be recorded by the Biodex balance system in the beginning with out any disturbance to the child attention, and then recorded during each task performed within their assigned group. Low OSI value indicates good balance and stability, with minimal sway or movement. High OSI value indicates difficulty maintaining balance and stability, with increased sway or movement, potentially suggesting impaired motor control or balance problems.
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 28 Jul 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.
Asmaa Osama Sayed, PhD study chair
Assistant Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Cerebral Palsy, 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 4 inclusion and 5 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 28 Jul 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?
Overall stability index (OSI) (time frame: One hour). 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 28 Jul 2025.