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

January 16, 2026 updated by: Mostafa S Ali, Cairo University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11432
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
balance
Time Frame: 3 months
3. Biodex balance system was used to evaluate the postural stability and dynamic balance of children
3 months
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mostafa s Ali, PhD, associate professor of physical therapy for pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2025

Primary Completion (Actual)

November 10, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005784

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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