ClinicalTrials.gg
RecruitingNCT07919002cerebral palsyUpdated Nov 5, 2026

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 in Gross Motor, sponsored by October 6 University. Recruiting at 2 sites in Egypt. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by October 6 University · Observational

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
3 Years to 5 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gross Motor
03

In context

Lead sponsor

October 6 University is the lead sponsor of 148 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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 criteria

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 will be ranged from 18-23 Exclusion Criteria:-

  1. Children with congenital anomalies and chromosomal disease.
  2. Children with recent musculoskeletal surgery.
  3. Mentally retarded -
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Target follow-up
4 Days
Patient registry
Yes

Interventions

  • Othergross motor group

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 days

Secondary outcomes

  1. 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

    Time frame: 4 days

  2. 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

    Time frame: 4 days

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Mar 2027, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2026
First posted
Nov 5, 2026
StartActual
Oct 13, 2026
Primary completionEst.
Mar 30, 2027
CompletionEst.
Apr 1, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07919002
Responsible party
heba Haridy (lecturer of basic science department, October 6 University) — Principal investigator
First posted
Nov 5, 2026
Start date
Oct 13, 2026
Primary completion
Mar 30, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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