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

NCT07346430 | Completed DMC

• 1 other identifier: P.T.REC/012/005784
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Spasticity; Cerebral Palsy

Keywords

anxiety; balance; spasticity; function; cerebral palsy

Outcome Measures

Primary Outcomes (3)

• function

  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

  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

• balance

  3\. Biodex balance system was used to evaluate the postural stability and dynamic balance of children

  3 months

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy; Anxiety Disorders; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mostafa s Ali, PhD

  associate professor of physical therapy for pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: August 14, 2025
• Primary Completion: November 10, 2025
• Study Completion: December 30, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

EG (1)