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

NCT05014451 | Unknown

• 1 other identifier: P.T.REC/012/003257
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Palsy; Spastic Diplegia

Keywords

pelvic alignment; pelvic tilt, torsion, inclination; Formetric; Biodex; dynamic balance; selective motor control; SCALE

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• The Children will be excluded if they have one of the following:
• Severe visual or hearing impairment.
• Fixed deformities or surgical interventions in the lower extremities.
• Botulinum toxin injections in the last 6 months.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 20, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after completion of statistical analysis of the results.
• Access Criteria: The data will be shared upon request.