Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia

This study will be conducted to identify the relation between pelvic alignment and standing balance and also the relation between pelvic alignment and selective motor control in children with spastic diplegic cerebral palsy.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy; Spastic Diplegia

Detailed Description

In this study, pelvic alignment of children with diplegia will be evaluated using the Formetric instrument system. Their standing balance will be evaluated using the Biodex balance system, while selective voluntary motor control of lower extremities will be assessed using the Selective Control Assessment of the Lower Extremity scale (SCALE).

Results will be compared to find the correlation between pelvic alignment and standing balance and the correlation between pelvic alignment and selective motor control. Results can help clinicians to better address the problems of pelvic asymmetry in children with spastic diplegia to improve their overall balance and functional abilities.

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with spastic diplegia, their height will not be less than 1 meter to meet the requirements of assessment by the Biodex and Formetric systems. They will be able to stand without the use of an assistive device and they will be able to follow instructions and understand given orders.

Description

Forty children with spastic diplegia of both sexes will be selected with the following criteria:

Inclusion Criteria:

1. Their age will be ranged from 6 to 8 years.
2. The degree of their spasticity will be ranged from 1 to 1+ according to Modified Ashworth' Scale.
3. They will be on level Ⅰ or Ⅱ on Growth Motor Function Classification System (GMFCS).

Exclusion Criteria:

The Children will be excluded if they have one of the following:

1. Severe visual or hearing impairment.
2. Fixed deformities or surgical interventions in the lower extremities.
3. Botulinum toxin injections in the last 6 months.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic alignment in relation to dynamic standing balance	Pelvic alignment will be assessed using the Formetric system, while standing balance will be assessed using the Biodex system then results will be compared to find the relation between pelvic alignment and dynamic standing balance in children with diplegia.	2 months
Pelvic alignment in relation to selective voluntary motor control of the lower extremities	Pelvic alignment will be assessed using the Formetric system, while selective motor control (SMC) of lower extremities will be assessed using Selective Control Assessment of the Lower Extremity scale (SCALE) then results will be compared to find the relation between pelvic alignment and selective motor control in children with diplegia.	2 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: dynamic balance; selective motor control; Biodex; pelvic alignment; pelvic tilt, torsion, inclination; Formetric; SCALE
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: P.T.REC/012/003257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be shared.
• IPD Sharing Time Frame: The data will be available after completion of statistical analysis of the results.
• IPD Sharing Access Criteria: The data will be shared upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No