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OpenTrials
Completed

NCT Number: NCT07346430

Does Anxiety Affect Balance, Spasticity and Function in Children With Cerebral Palsy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • significant visual, auditory, or perceptual deficits
  • uncontrolled seizures
  • acute illness

Treatment and study plan

Primary outcomes

  1. 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

    • = initiates
    • = partially completes
    • = completes
  2. 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

    • 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
  3. balance

    Time frame: 3 months

    • Biodex balance system was used to evaluate the postural stability and dynamic balance of children

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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