Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with Cerebral Palsy

1. To better understand the factors that contribute to ROM abnormalities in children diagnosed with CP.
2. To describe the distribution of primary (muscle tone and postural stability)and secondary impairments (ROM and functional muscle strength) across the gross motor spectrum measured by GMFCS scores.
3. To evaluate the effects of primary and secondary impairments on gross functional outcome in children with spastic CP.
4. To find any possible correlation between clinical variables.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Diagnostic test: balance and range of motion

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: ahmed fekry salman; Phone Number: +201067873174; Email: a.salman@ammanu.edu.jo

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Physical Therapy Cairo University
    • Contact: mahmoud usama; Phone Number: +21285221209; Email: afekry335@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

children with cerebral plasy their age ranged fro 18 month t 5 yeas old

Description

Inclusion Criteria:

• only children with clinical diagnosis of cerebral palsy , who were receiving physiotherapy services at the paediatric out-patient clinic of Faculty of Physical Therapy, Cairo University for a minimum of six months regularly.

Exclusion Criteria:

• Children were excluded if they had one or more of the following: behavioral issues, a history of persistent heart or chest disease, significant visual or auditory impairment, botulinum toxin injection at last six months prior to the study.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
diplegic cerebral palsy	Diagnostic test: balance and range of motion; Spinal alignment and range of motion measure scale (SAROMM): is a measure of spinal alignment and range of motion using standard physical therapy techniques scored on a 5-point ordinal score of 0 (normal alignment and range with active correction) to4 ("severe" fixed deformity) (Bartlett ey al., 2005); Modified Ashworth scale (MAS): is a measure of muscle motion and scoring the perceived resistance to movement on a scale of 1 (no increase in tone) to 5 (rigid in flexion or extension) (Clopton et al., 2005).; Early clinical assessment of balance (ECAB) scale: Is a 13-item test that estimates postural stability for children with CP across all levels of functional ability (Jeffries etal., 2016).; Functional strength assessment scale: Therapists completed a functional strength assessment (FSA) to obtain an estimate of strength for major muscle groups including the neck and trunk flexors and extensors, and hip extensors, knee extensors, and shoulder flexors bilaterally.; Other Names: Spinal alignment and range of motion measure scale; Modified Ashworth scale (MAS); Early clinical assessment of balance (ECAB) scale; Functional strength assessment scale
quadripledic cerebral palsy	Diagnostic test: balance and range of motion; Spinal alignment and range of motion measure scale (SAROMM): is a measure of spinal alignment and range of motion using standard physical therapy techniques scored on a 5-point ordinal score of 0 (normal alignment and range with active correction) to4 ("severe" fixed deformity) (Bartlett ey al., 2005); Modified Ashworth scale (MAS): is a measure of muscle motion and scoring the perceived resistance to movement on a scale of 1 (no increase in tone) to 5 (rigid in flexion or extension) (Clopton et al., 2005).; Early clinical assessment of balance (ECAB) scale: Is a 13-item test that estimates postural stability for children with CP across all levels of functional ability (Jeffries etal., 2016).; Functional strength assessment scale: Therapists completed a functional strength assessment (FSA) to obtain an estimate of strength for major muscle groups including the neck and trunk flexors and extensors, and hip extensors, knee extensors, and shoulder flexors bilaterally.; Other Names: Spinal alignment and range of motion measure scale; Modified Ashworth scale (MAS); Early clinical assessment of balance (ECAB) scale; Functional strength assessment scale
hemiplegic cerebral palsy	Diagnostic test: balance and range of motion; Spinal alignment and range of motion measure scale (SAROMM): is a measure of spinal alignment and range of motion using standard physical therapy techniques scored on a 5-point ordinal score of 0 (normal alignment and range with active correction) to4 ("severe" fixed deformity) (Bartlett ey al., 2005); Modified Ashworth scale (MAS): is a measure of muscle motion and scoring the perceived resistance to movement on a scale of 1 (no increase in tone) to 5 (rigid in flexion or extension) (Clopton et al., 2005).; Early clinical assessment of balance (ECAB) scale: Is a 13-item test that estimates postural stability for children with CP across all levels of functional ability (Jeffries etal., 2016).; Functional strength assessment scale: Therapists completed a functional strength assessment (FSA) to obtain an estimate of strength for major muscle groups including the neck and trunk flexors and extensors, and hip extensors, knee extensors, and shoulder flexors bilaterally.; Other Names: Spinal alignment and range of motion measure scale; Modified Ashworth scale (MAS); Early clinical assessment of balance (ECAB) scale; Functional strength assessment scale
dyskinetic cerebral palsy	Diagnostic test: balance and range of motion; Spinal alignment and range of motion measure scale (SAROMM): is a measure of spinal alignment and range of motion using standard physical therapy techniques scored on a 5-point ordinal score of 0 (normal alignment and range with active correction) to4 ("severe" fixed deformity) (Bartlett ey al., 2005); Modified Ashworth scale (MAS): is a measure of muscle motion and scoring the perceived resistance to movement on a scale of 1 (no increase in tone) to 5 (rigid in flexion or extension) (Clopton et al., 2005).; Early clinical assessment of balance (ECAB) scale: Is a 13-item test that estimates postural stability for children with CP across all levels of functional ability (Jeffries etal., 2016).; Functional strength assessment scale: Therapists completed a functional strength assessment (FSA) to obtain an estimate of strength for major muscle groups including the neck and trunk flexors and extensors, and hip extensors, knee extensors, and shoulder flexors bilaterally.; Other Names: Spinal alignment and range of motion measure scale; Modified Ashworth scale (MAS); Early clinical assessment of balance (ECAB) scale; Functional strength assessment scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predictors of range of motion and balance abnormalities	the aim of the study is to investigate the predicted cause if the range of motion abnormalities measured by (spinal alignment and range of motion assessment scale ) and balance abnormalities ( measured by early clinical assessment of balance scale )in children with cerebral palsy like muscle strength (measured by functional muscle strength scale) and muscle tone changes (measured by modified athwart scale)	from 1 august 2024 to 1 october 2024

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: September 15, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: P.T.REC/012/005209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No