NCT05428865

Brief 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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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

January 24, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

June 11, 2022

Last Update Submit

February 13, 2023

Conditions

Keywords

isolated motor controlfunctional abilitybody mass indexcerebral palsy

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Modified Ashworth Scale (MAS)

    through study completion, an average of 1 year

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

    through study completion, an average of 1 year

Interventions

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

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

spastic diplegic cerebral palsy children

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Faculty OP Therapy, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

June 11, 2022

First Posted

June 23, 2022

Study Start

January 24, 2022

Primary Completion

June 1, 2022

Study Completion

July 24, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations