Clinical trial NCT04997044: Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia
Official title: A Randomized Controlled Study Investigating the Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: standard orthotic management
Selective dorsal rhizotomy
Bilateral Cerebral Palsy
Functional balance
Energy Cost of Walking
Functional capacity
Selective voluntary motor control:
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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
* Moderate to severe signs of dystonia, athetosis or ataxia.

Primary outcomes:
measure: Functional Balance
timeFrame: after 6 months and after 1 year (follow-up)
measure: Gross motor function
timeFrame: after 6 months and after 1 year (follow-up)
Secondary outcomes:
measure: Selective voluntary motor control
timeFrame: after 6 months and after 1 year (follow-up)
measure: Energy cost of walking
timeFrame: after 6 months and after 1 year (follow-up)
measure: Functional capacity
timeFrame: after 6 months and after 1 year (follow-up)
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Amira Mahmoud Abd-elmonem
Study officials:
affiliation: PhD of physical therapy for pediatrics, faculty of physical therapyCairo university
name: Hazem A Aly, Phd
role: STUDY_CHAIR
affiliation: Department of neurosurgery, faculty of medicine , Alexandria university
name: Ahmed Rabie, Phd
role: STUDY_DIRECTOR
affiliation: Cairo university, faculty of physical therapy
name: Sara S Saad-Eldien, PhD
role: PRINCIPAL_INVESTIGATOR
References: