Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Concomitant physical rehabilitation; Other: Standard Orthotic Management; Other: selective dorsal rhizotomy

• Registration Number: NCT04997044
• Lead Sponsor: Cairo University

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)

Study Timeline

• Study Start: 2020-10-20
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-09
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Standard Orthotic Management	control group
Experimental group	Concomitant physical rehabilitation	selective dorsal rhizotomy group
control group	Concomitant physical rehabilitation	control group
Experimental group	selective dorsal rhizotomy	selective dorsal rhizotomy group
Experimental group	Standard Orthotic Management	selective dorsal rhizotomy group

Primary Outcome Measures

Name	Time	Method
Functional Balance	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	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 Outcome Measures

Name	Time	Method
Selective voluntary motor control	after 6 months and after 1 year (follow-up)	Selective motor control of lower extremity scale is used for assessment of motor control of the lower limb joints in children with spastic cerebral palsy with a maximum score of 20 points, 10 points for each limb.
Energy cost of walking	after 6 months and after 1 year (follow-up)	The energy expenditure index (beats/meter) can be calculated as; walking heart rate (beats/min) minus resting heart rate (beats/ min) on walking velocity (meters/min).
Functional capacity	after 6 months and after 1 year (follow-up)	The six-minute walking test is used to assess walking capacity in children with and without disabilities.

Trial Locations

Locations (1)

Amira Mahmoud Abd-elmonem; 🇪🇬 Giza, Egypt