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Completed

NCT Number: NCT05428865

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

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?

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Key information

Conditions

Diplegic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty Of Physical Therapy

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Correlation Study

Other

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

Primary outcomes

  1. The selective control assessment of lower extremity (SCALE)

    Time frame: through study completion, an average of 1 year

    is a tool used for assessment of SVMC in children with spastic CP.

  2. Anthropometric measurements

    Time frame: through study completion, an average of 1 year

    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

  3. Wee Functional Independence Measure (Wee-FIM)

    Time frame: through study completion, an average of 1 year

    is a tool used to assess activities of daily living (ADL) in children with cerebral palsy.

Secondary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: through study completion, an average of 1 year

    For grading degree of spasticity.

  2. Gross Motor Function Classification System Expanded and Revised for CP children between 6th and 12th birthday:

    Time frame: through study completion, an average of 1 year

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2022
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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