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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06124352
Other study ID # Clinical Measure Scales
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date October 6, 2023

Study information

Verified date November 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 6, 2023
Est. primary completion date August 28, 2023
Accepts healthy volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Gross Motor Function Measurement - 66 (GMFM- 66)
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
Bruininks- Oseretsky Motor Proficiency
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 Peabody Developmental Motor Scale - Second Edition (PDMS-2
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].

Locations

Country Name City State
Egypt Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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