NCT06601569

Brief Summary

  1. 1.To better understand the factors that contribute to ROM abnormalities in children diagnosed with CP.
  2. 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. 3.To evaluate the effects of primary and secondary impairments on gross functional outcome in children with spastic CP.
  4. 4.To find any possible correlation between clinical variables.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

July 27, 2024

Last Update Submit

September 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

diplegic cerebral palsy

Diagnostic Test: balance and range of motion

quadripledic cerebral palsy

Diagnostic Test: balance and range of motion

hemiplegic cerebral palsy

Diagnostic Test: balance and range of motion

dyskinetic cerebral palsy

Diagnostic Test: balance and range of motion

Interventions

* 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.

Also known as: Spinal alignment and range of motion measure scale, Modified Ashworth scale (MAS), Early clinical assessment of balance (ECAB) scale, Functional strength assessment scale
diplegic cerebral palsydyskinetic cerebral palsyhemiplegic cerebral palsyquadripledic cerebral palsy

Eligibility Criteria

Age18 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

ahmed fekry salman

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor physical therapy department

Study Record Dates

First Submitted

July 27, 2024

First Posted

September 19, 2024

Study Start

August 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Locations