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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05014451
Other study ID # P.T.REC/012/003257
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 30, 2021

Study information

Verified date October 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 30, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Years to 8 Years
Eligibility 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 ? or ? 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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