NCT07012122

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

June 1, 2025

Last Update Submit

July 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    One hour

Study Arms (3)

Group of visual spatial memory task

It will consist of 21 children, who will perform a visual spatial memory task.

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.

Other: nonspatial verbal memory task

Group of visuomotor tracking task

It will consist of 21 children, who will perform a visuomotor tracking task.

Other: visuomotor tracking task

Interventions

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.

Group of visual spatial memory task

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.

Group of nonspatial verbal memory task

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.

Group of visuomotor tracking task

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Asmaa Osama Sayed, PhD

    Assistant Professor, Cairo university

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 10, 2025

Study Start

June 10, 2025

Primary Completion

July 10, 2025

Study Completion

July 20, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations