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Clinical Trials/NCT04997044
NCT04997044
Completed
Not Applicable

A Randomized Controlled Study Investigating the Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia

Cairo University1 site in 1 country42 target enrollmentOctober 20, 2020
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Cairo University
Enrollment
42
Locations
1
Primary Endpoint
Functional Balance
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The management of cerebral palsy is complex and requires a multidisciplinary approach. Selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the lower limbs and improve motor function.

Detailed Description

the current study is designed to assess the effectiveness of Selective dorsal rhizotomy on motor function in ambulant children with spastic diplegia. therefore, A convenient sample of ambulant children with spastic diplegia will be allocated to two groups of equal numbers (control and experimental)

Registry
clinicaltrials.gov
Start Date
October 20, 2020
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amira Mahmoud Abd-elmonem

Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Cairo University

Eligibility Criteria

Inclusion Criteria

  • CP, spastic diplegia
  • 4-8 years of age
  • The ability to walk with or without assistive devices typically on Level II-III on Gross Motor Function Classification System
  • At least six months after the last Botulinum toxin A injection in the lower extremities
  • Average intelligent quotient according to medical records for active participation
  • Good trunk control with good antigravity strength of lower extremity on clinical examination.
  • Exclusionary criteria
  • Ankle clonus; exaggerated deep tendon reflex in the legs
  • Babinski sign
  • Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Functional Balance

Time Frame: after 6 months and after 1 year (follow-up)

The pediatric balance scale was used to assess the child's functional performance with total score is 56 and higher score representing a better performance.

Gross motor function

Time Frame: after 6 months and after 1 year (follow-up)

The gross motor function measure-88 is used to evaluate the motor function with total score is 100 and higher scores representing a better performance.

Secondary Outcomes

  • Selective voluntary motor control(after 6 months and after 1 year (follow-up))
  • Energy cost of walking(after 6 months and after 1 year (follow-up))
  • Functional capacity(after 6 months and after 1 year (follow-up))

Study Sites (1)

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