Correlation Between Body Mass Index, Selective Motor Control and Functional Ability in Children With CP

Diplegic Cerebral Palsy Clinical Trial

Official title:

Correlation Between Body Mass Index, Selective Motor Control, Spasticity and Functional Ability in Children With Diplegic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428865
• Other study ID #: P.T.REC/012/003833
• Status: Completed
• Start date: January 24, 2022
• Est. completion date: July 24, 2022

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PURPOSE:

To investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.

BACKGROUND:

Cerebral palsy is primarily a disorder of movement and posture

HYPOTHESES:

There is no correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.

RESEARCH QUESTION:

Is there a correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia?

Description:

This is an observational correlational study. SCALE will be used to assess selective motor control of lower extremity. GMFM-88 and WEE FIM will be used to assess functional ability. MAS will be used to assess degree of spasticity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 24, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

• spastic diplegic CP, age from 6 to 9 years, able to follow verbal commands or instructions during testing procedures, 1+ and 2 according to Modified Ashworth scale (MAS), (GMFCS E&R) selected Level II , III.

Exclusion Criteria:

• patients who had contractures or fixed deformities related to the joints of the lower limbs, injection with Botulinium toxin or any orthopaedic surgery in lower limbs within one year before study,

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegic Cerebral Palsy

Intervention

Other:
• correlation study
investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.

Locations

Country	Name	City	State
Egypt	Faculty Of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The selective control assessment of lower extremity (SCALE)	is a tool used for assessment of SVMC in children with spastic CP.	through study completion, an average of 1 year
Primary	Anthropometric measurements	include weight (measured using a calibrated digital scale and height (measured using Harpenden Stadiometer). Body mass index (BMI) was calculated as weight (kg)/height (m2). higher scores indicate obesity	through study completion, an average of 1 year
Primary	Wee Functional Independence Measure (Wee-FIM)	is a tool used to assess activities of daily living (ADL) in children with cerebral palsy.	through study completion, an average of 1 year
Secondary	Modified Ashworth Scale (MAS)	For grading degree of spasticity.	through study completion, an average of 1 year
Secondary	Gross Motor Function Classification System Expanded and Revised for CP children between 6th and 12th birthday:	The Gross Motor Function Classification System (GMFCS E&R) is a classification system that describes the level of gross motor function of CP children according to abilities and limitations	through study completion, an average of 1 year