Cerebral PalsyNCT07346430
Does Anxiety Affect Balance, Spasticity and Function in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Anxiety, run by Cairo University at 1 site in Egypt.
Trial summary
children and adolescents with CP are at increased risk of developing mental health difficulties, particularly anxiety disorders, compared with their typically developing peers. this study was to investigate the correlation between anxiety, spasticity and balance in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Cerebral Palsy, Anxiety, Spasticity
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Aug 2025to 30 Dec 2025
- How long will I take part?
- 3 Months
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: POWER statistical programming was used to test size estimation [Exact Correlation: Bivariate normal model, α = 0.05, β = 0.20, number of variables = 2, correlation ρH0 = 0, correlation ρH1 = 0.81, and coefficient of determination ρ2 = 0.66 and shown that the suitable sample size of current study was N = 13]. This coefficient of determination ρ2 was calculated from a pilot study of ten participants (between grades of spasticity and gross motor function).
Who may be able to join
- age 4-8 years from both genders
- diagnosed as hemiplegia and diplegia
- Gross Motor Function Classification System (GMFCS) levels I or II
- spasticity grade of 1 or I+ on the modified Ashworth Scale
Who cannot join
- significant visual, auditory, or perceptual deficits
- uncontrolled seizures
- acute illness
Trial locations and contacts
1 site in 1 country.
About this study
children and adolescents with CP are at increased risk of developing mental health difficulties, particularly anxiety disorders, compared with their typically developing peers. this study was to investigate the correlation between anxiety, spasticity and balance in children with cerebral palsy.
Read the detailed description
forty children with hemiplegia and diplegia were recruited from outpatient clinic of faculty of physical therapy, Cairo University and October 6 University. These children aged from 4 to 8 years old. Anxiety, motor function, spasticity and balance were assessed by Modified Yale Pre-Operative Anxiety Scale ((m -YPAS), The Gross Motor Functional Measurement-88 (GMFM-88), the modified Ashworth scale and Biodex balance system respectively.
- Conditions
- Cerebral Palsy, Anxiety, Spasticity
- Keywords
- anxiety, balance, spasticity, function, cerebral palsy
- Medical subject headings
- Cerebral Palsy, Anxiety Disorders, Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
function
The Gross Motor Functional Measurement-88 used to measure function. The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate
- = initiates
- = partially completes
- = completes
Measured: 3 months
spasticity
The modified Ashworth scale was used to measure spasticity. The test is performed by extending the patients limb's first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion.
Scoring 0 No Increased in tone
- Slight increase in tone giving a catch when the limb is moved in flexion or extension 1+ Slight increase in muscle tone, indicated by a catch followed by minimal resistance throughout range of motion (ROM)
- More marked increase in tone through most of the ROM, but the limb easily flexed
- Considerable increase in tone, passive movement difficult
- Limb rigid in flexion or extension
Measured: 3 months
balance
- Biodex balance system was used to evaluate the postural stability and dynamic balance of children
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 posted16 Jan 2026
- Study start14 Aug 2025
- Primary completion10 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa S Ali, Cairo University
- Investigators
- Mostafa s Ali, PhD, Principal investigator, associate professor of physical therapy for pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346430
- Sponsor's protocol ID
- P.T.REC/012/005784
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 20 Jan 2026
- 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Anxiety Affect Balance, Spasticity and Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07346430
- Acronym / sponsor ID
- P.T.REC/012/005784
- Conditions
- Cerebral Palsy, Anxiety, Spasticity
- Keywords
- anxiety, balance, spasticity, function, cerebral palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 16 Jan 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.
children and adolescents with CP are at increased risk of developing mental health difficulties, particularly anxiety disorders, compared with their typically developing peers. this study was to investigate the correlation between anxiety, spasticity and balance in children with cerebral palsy.
Detailed description
forty children with hemiplegia and diplegia were recruited from outpatient clinic of faculty of physical therapy, Cairo University and October 6 University. These children aged from 4 to 8 years old. Anxiety, motor function, spasticity and balance were assessed by Modified Yale Pre-Operative Anxiety Scale ((m -YPAS), The Gross Motor Functional Measurement-88 (GMFM-88), the modified Ashworth scale and Biodex balance system respectively.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- POWER statistical programming was used to test size estimation [Exact Correlation: Bivariate normal model, α = 0.05, β = 0.20, number of variables = 2, correlation ρH0 = 0, correlation ρH1 = 0.81, and coefficient of determination ρ2 = 0.66 and shown that the suitable sample size of current study was N = 13]. This coefficient of determination ρ2 was calculated from a pilot study of ten participants (between grades of spasticity and gross motor function).
Key inclusion criteria (4 listed)
- age 4-8 years from both genders
- diagnosed as hemiplegia and diplegia
- Gross Motor Function Classification System (GMFCS) levels I or II
- spasticity grade of 1 or I+ on the modified Ashworth Scale
Key exclusion criteria (3 listed)
- significant visual, auditory, or perceptual deficits
- uncontrolled seizures
- acute illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
function
Time frame: 3 months
The Gross Motor Functional Measurement-88 used to measure function. The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes
spasticity
Time frame: 3 months
The modified Ashworth scale was used to measure spasticity. The test is performed by extending the patients limb's first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Scoring 0 No Increased in tone 1. Slight increase in tone giving a catch when the limb is moved in flexion or extension 1+ Slight increase in muscle tone, indicated by a catch followed by minimal resistance throughout range of motion (ROM) 2. More marked increase in tone through most of the ROM, but the limb easily flexed 3. Considerable increase in tone, passive movement difficult 4. Limb rigid in flexion or extension
balance
Time frame: 3 months
3. Biodex balance system was used to evaluate the postural stability and dynamic balance of children
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 Jan 2026.
Related trials for Cerebral Palsy
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
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.
Mostafa s Ali, PhD principal investigator
associate professor of physical therapy for pediatrics
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 Cerebral Palsy and Anxiety, 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 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 20 Jan 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?
function (time frame: 3 months). The study lists 3 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 Jan 2026.