NCT06124352

Brief Summary

Evaluating and applying an early and consistent rehabilitation approach to children with neurological impairments requires a multidisciplinary approach that involves different specialists, including pediatricians, pediatric neurologists, professional therapists, and pediatric physical therapists. Evaluation is essential to validate the judgment, monitor the source, and evaluate the mechanical function and related difficulties.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 4, 2023

Last Update Submit

November 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The principal purpose of this study is to find the correlation between the clinical measurement scales for gross motor function in young CP children

    For this study, a correlation between these 3 categories of clinical measures scales was analyzed in diplegic patients.

    6 months

Interventions

GMFM-66 was performed for participants established on self-independent motion, with importance on allocations, and motion. The emphasis is to detect the grade that greatest reveals the current skills and disabilities of the child regarding motor functions. The new Gross Motor Ability Estimator (GMAE) scoring method for test-retest reliability data showed a high level of stability of the GMFM-66 over time (ICC=0.9932) that did not differ since the original GMFM 88-item test-retest reliability

The BOT-2 are scale used to evaluate fine and gross motion skill development. It's used to classify children with movement control limitation. The test is appropriate for those aged 4 to 21 years. The interrater reliability ranging from 0.92 to 0.99 and construct validity. r = 0.78 (0.56 - 0.86) (test grades / chronological age)

The PDMS-2 is a consistent test that evaluates a child's movement skills. It is norm-referenced and consists of three composites: Fine Motor (FM), Gross Motor (GM), and Total movement composites (TM). GM composite incorporates 151 points from four sub-tests: reflexes, stationary, locomotion, and object manipulation. A 3-point scale scored for each item, with 2 being the highest score. Definite criterion for score of 2 is given when the child achieves the item, 1 is given when the behavior is emerging but not fully met, and 0 is given when the child cannot achieve the point. The highest raw scores of the sub-tests range from 16 to 198. The test-retest reliability of PDMS-2 was found to be r = 0.85 \[24, 25\].

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

In this single-group cross-sectional study design, 50 participants with diplegic CP from the ages of 4 and 6 years evaluated in a physical therapy outpatient clinic and receiving a physiotherapy program for at minimum 6 months were included

You may qualify if:

  • children with spastic CP with the capability to keep a standing position alone for at minimum five seconds, and the grade of hypertonicity in the lower extremity varied from grade 1 to grade 2 on the Modified Ashworth Scale with the capability to collaborate and follow directives

You may not qualify if:

  • Children were excluded If they had a serious neurological condition (epilepsy), orthopedic complications, leg surgery, botulinum toxin treatment in the lower extremity in the last 6 months before the study and suffered from advanced intellectual disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, 11234, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at faculty of physical therapy

Study Record Dates

First Submitted

November 4, 2023

First Posted

November 9, 2023

Study Start

May 15, 2023

Primary Completion

August 28, 2023

Study Completion

October 6, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations