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

NCT ID: NCT04997044

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2022-06-30

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)

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

control group

Group Type: OTHER

Concomitant physical rehabilitation

Intervention Type: OTHER

Children of this group will receive a regular exercise rehabilitation program including starching exercises, functional strength training and static and dynamic balance exercises.The program will be conducted by six licensed pediatric physical therapists for one hour/session, 3 times/week, and six successive months.

Standard Orthotic Management

Intervention Type: OTHER

A custom-made articulating ankle foot orthosis was prescribed with a hinge at the level of the medial malleolus extends distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured straps. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day.

Experimental group

selective dorsal rhizotomy group

Group Type: EXPERIMENTAL

Concomitant physical rehabilitation

Intervention Type: OTHER

Children of this group will receive a regular exercise rehabilitation program including starching exercises, functional strength training and static and dynamic balance exercises.The program will be conducted by six licensed pediatric physical therapists for one hour/session, 3 times/week, and six successive months.

Standard Orthotic Management

Intervention Type: OTHER

A custom-made articulating ankle foot orthosis was prescribed with a hinge at the level of the medial malleolus extends distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured straps. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day.

selective dorsal rhizotomy

Intervention Type: OTHER

The surgical procedures were tailored to each child according to preoperative assessment plan. All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact.

Interventions

Concomitant physical rehabilitation

Children of this group will receive a regular exercise rehabilitation program including starching exercises, functional strength training and static and dynamic balance exercises.The program will be conducted by six licensed pediatric physical therapists for one hour/session, 3 times/week, and six successive months.

Intervention Type: OTHER

Standard Orthotic Management

A custom-made articulating ankle foot orthosis was prescribed with a hinge at the level of the medial malleolus extends distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured straps. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day.

Intervention Type: OTHER

selective dorsal rhizotomy

The surgical procedures were tailored to each child according to preoperative assessment plan. All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mahmoud Abd-elmonem

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hazem A Aly, Phd

Role: STUDY_CHAIR

PhD of physical therapy for pediatrics, faculty of physical therapyCairo university

Ahmed Rabie, Phd

Role: STUDY_DIRECTOR

Department of neurosurgery, faculty of medicine , Alexandria university

Sara S Saad-Eldien, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo university, faculty of physical therapy

Locations

Amira Mahmoud Abd-elmonem

Giza, , Egypt

Countries

Egypt

Other Identifiers

selective dorsal rhizotomy

Identifier Type: -

Identifier Source: org_study_id