Gross Motorcerebral palsyNCT07919002
The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
An observational study of Gross Motor, run by October 6 University at 2 sites in Egypt.
Trial summary
Caregiving for cerebral palsy children covers a very wide range of activities such as heavy lifting and turning, bathing, helping the child to use the toilet, getting the child to sleep, dressing and assisting the transfer causes burden of care because these children are different from normal ones and need extra care… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Gross Motor
- What is being tested?
- gross motor group
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 13 Oct 2026to 1 Apr 2027
- How long will I take part?
- 4 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Sixty cerebral palsy child from both sexes will participate in this study with their mothers They will be selected from the outpatient clinic of Faculty of Physical Therapy of Cairo University and October 6 University
Inclusion Criteria:1- Their age will be ranged from 3 to 5 years. 2- Children with clinical diagnosis of bilateral spastic cerebral palsy 3-Their functional level will be ranged from I to V according to Gross motor function classification system 4-Their BMI will be ranged from 18-23 Exclusion Criteria:-
- Children with congenital anomalies and chromosomal disease.
- Children with recent musculoskeletal surgery.
- Mentally retarded -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Heba
Cairo
Heba ahmed, lecturer of basic science, 01117671713, Heba.Ahmed.PT@o6u.edu.eg
menna Abass, 01202299885, PT@o6u.edu.eg
- Recruiting
faculty of physical therapy October 6 university
Giza
Heba ahmed, lecturer of basic science, 01117671713, Heba.Ahmed.PT@o6u.edu.eg
About this study
Caregiving for cerebral palsy children covers a very wide range of activities such as heavy lifting and turning, bathing, helping the child to use the toilet, getting the child to sleep, dressing and assisting the transfer causes burden of care because these children are different from normal ones and need extra care and attention in regards to their physical disabilities and limitations. This type of burden may adversely impact on caregiver's physical and mental functioning.
Read the detailed description
Low back pain develops more periods when transferring their children, manual handling can put long term physical strain on mothers and be a contributing factor to a higher pain Severity. The mothers of children with CP report not only declined physical and mental health, but also fatigue and impaired quality of life. Frequently in mothers being exposed to more physical load for longer.
- Conditions
- Gross Motor
- Being tested
- gross motor group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gross motor groupOther
The examination for children's gross motor function, assessed using the Gross Motor Function Measure-66 (GMFM-66), and maternal low back pain-related disability measured by the Oswestry Disability Index (ODI), as well as overall health-related quality of life assessed using the Short Form-36 (SF-36).
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure
The Gross Motor Function Measure-66 (GMFM-66) is a standardized observational assessment designed to evaluate gross motor function in individuals with motor impairments. It consists of 66 items derived from the original GMFM-88 and assesses activities across five dimensions.
Measured: 4 days
Secondary outcomes (2)
Arabic Version of the Oswestry Low Back Pain Disability Questionnaire
he Arabic Version of the Oswestry Low Back Pain Disability Questionnaire is a self-administered, condition-specific outcome measure used to evaluate disability associated with low back pain. pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment or homemaking. Each section is scored from 0 to 5, with the total score expressed as a percentage, where higher scores indicate greater disability
Measured: 4 days
The Short Form-36 Health Survey
The Short Form-36 Health Survey (SF-36) is a widely used, generic, self-administered questionnaire developed to assess health-related quality of life . It consists of 36 items that evaluate eight health domains
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start13 Oct 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gross MotorStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba Haridy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919002
- Sponsor's protocol ID
- 000116
- Acronym
- cerebral palsy
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
- ClinicalTrials.gov ID
- NCT07919002
- Acronym / sponsor ID
- cerebral palsy / 000116
- Conditions
- Gross Motor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Nov 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.
Caregiving for cerebral palsy children covers a very wide range of activities such as heavy lifting and turning, bathing, helping the child to use the toilet, getting the child to sleep, dressing and assisting the transfer causes burden of care because these children are different from normal ones and need extra care and attention in regards to their physical disabilities and limitations. This type of burden may adversely impact on caregiver's physical and mental functioning.
Detailed description
Low back pain develops more periods when transferring their children, manual handling can put long term physical strain on mothers and be a contributing factor to a higher pain Severity. The mothers of children with CP report not only declined physical and mental health, but also fatigue and impaired quality of life. Frequently in mothers being exposed to more physical load for longer.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Days
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Sixty cerebral palsy child from both sexes will participate in this study with their mothers They will be selected from the outpatient clinic of Faculty of Physical Therapy of Cairo University and October 6 University
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 |
|---|---|---|
| gross motor groupThe examination for children's gross motor function, assessed using the Gross Motor Function Measure-66 (GMFM-66), and maternal low back pain-related disability measured by the Oswestry Disability Index (ODI), as well as overall health-related quality of life assessed using the Short Form-36 (SF-36). | Other | – |
Primary outcome
Gross Motor Function Measure
Time frame: 4 days
The Gross Motor Function Measure-66 (GMFM-66) is a standardized observational assessment designed to evaluate gross motor function in individuals with motor impairments. It consists of 66 items derived from the original GMFM-88 and assesses activities across five dimensions.
2 secondary outcomes
Arabic Version of the Oswestry Low Back Pain Disability Questionnaire
Time frame: 4 days
The Short Form-36 Health Survey
Time frame: 4 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gross Motor, run by October 6 University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (time frame: 4 days). 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 5 Nov 2026.