Effects of Selective Dorsal Rhizotomy on Non-ambulant Children With Bilateral Spastic Cerebral Palsy

NCT ID: NCT05006144

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2022-01-30

Brief Summary

Children with spastic bilateral cerebral palsy are late developers. delayed gross and fine motor development require early intervention to improve the child performance and avoid secondary impairments.

Detailed Description

increased tone of lower extremity muscles interfere with the child sitting posture and trunk control. delayed sitting and lack of trunk control contribute to the impairments of upper extremity functions.

selective dorsal rhizotomy is a surgical procedure to control increased tone of the lower extremities. Therefore, the current study is carried out to investigate the effects of selective dorsal rhizotomy on trunk control, selectivity and upper extremity function of non-ambulant children with bilateral spastic cerebral palsy

Conditions

Bilateral 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

sequenced trunk co-activation exercises

Intervention Type: OTHER

• Sequenced trunk co-activation exercises were basically used for facilitation of functional activities through trunk musculature dynamic co-activation of in the lateral plane which is required for basic developmental milestones. In the frontal plane, encourage the child to actively shift his/her weight to maintain the weight-bearing side straight while keeping proper active co-activation of trunk musculature. Efficient trunk rotation is essential for acquiring of equilibrium reactions and balance. Enhancement of efficient active trunk rotation as the child could achieve active trunk musculature co-activation while maintaining the weight-bearing side straight (Arndt et al., 2008).
• Righting and protective reactions
• Functional stretching exercises.

Standard Orthotic Management

Intervention Type: OTHER

A custom-made articulating ankle foot orthosis with a hinge at the level of the medial malleolus of the ankle is fabricated for each child from the same copolymer thermoplastic mold after casting with the subtalar joint in neutral position. The orthosis extended 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 to the foot by three straps across the forefoot, the front of the ankle, and to the anterior upper tibial portion. 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 in the third and fourth months to accommodate children to the orthosis.

Experimental group

selective dorsal rhizotomy

Group Type: EXPERIMENTAL

sequenced trunk co-activation exercises

Intervention Type: OTHER

• Sequenced trunk co-activation exercises were basically used for facilitation of functional activities through trunk musculature dynamic co-activation of in the lateral plane which is required for basic developmental milestones. In the frontal plane, encourage the child to actively shift his/her weight to maintain the weight-bearing side straight while keeping proper active co-activation of trunk musculature. Efficient trunk rotation is essential for acquiring of equilibrium reactions and balance. Enhancement of efficient active trunk rotation as the child could achieve active trunk musculature co-activation while maintaining the weight-bearing side straight (Arndt et al., 2008).
• Righting and protective reactions
• Functional stretching exercises.

Standard Orthotic Management

Intervention Type: OTHER

A custom-made articulating ankle foot orthosis with a hinge at the level of the medial malleolus of the ankle is fabricated for each child from the same copolymer thermoplastic mold after casting with the subtalar joint in neutral position. The orthosis extended 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 to the foot by three straps across the forefoot, the front of the ankle, and to the anterior upper tibial portion. 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 in the third and fourth months to accommodate children to the orthosis.

selective dorsal rhizotomy

Intervention Type: OTHER

All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact. After opening the dura, the posterior nerve roots of L2 to S1 were identified and divided into 3 to 6 rootlets. At L2, from 30% to 50% of the posterior nerve rootlets were sectioned without selective stimulation. Selective electric stimulation of each nerve rootlet was performed from L3 to S1. The percentage of rootlets sectioned at each level (table 3) was determined by the surgical team based on the electromyographic results obtained intrasurgically and knowledge of the presurgical assessment results. The laminae were replaced on the completion of the rootlet stimulation and secured with sutures in the yellow ligament and the supraspinous ligament.

Interventions

sequenced trunk co-activation exercises

• Sequenced trunk co-activation exercises were basically used for facilitation of functional activities through trunk musculature dynamic co-activation of in the lateral plane which is required for basic developmental milestones. In the frontal plane, encourage the child to actively shift his/her weight to maintain the weight-bearing side straight while keeping proper active co-activation of trunk musculature. Efficient trunk rotation is essential for acquiring of equilibrium reactions and balance. Enhancement of efficient active trunk rotation as the child could achieve active trunk musculature co-activation while maintaining the weight-bearing side straight (Arndt et al., 2008).
• Righting and protective reactions
• Functional stretching exercises.

Intervention Type: OTHER

Standard Orthotic Management

A custom-made articulating ankle foot orthosis with a hinge at the level of the medial malleolus of the ankle is fabricated for each child from the same copolymer thermoplastic mold after casting with the subtalar joint in neutral position. The orthosis extended 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 to the foot by three straps across the forefoot, the front of the ankle, and to the anterior upper tibial portion. 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 in the third and fourth months to accommodate children to the orthosis.

Intervention Type: OTHER

selective dorsal rhizotomy

All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact. After opening the dura, the posterior nerve roots of L2 to S1 were identified and divided into 3 to 6 rootlets. At L2, from 30% to 50% of the posterior nerve rootlets were sectioned without selective stimulation. Selective electric stimulation of each nerve rootlet was performed from L3 to S1. The percentage of rootlets sectioned at each level (table 3) was determined by the surgical team based on the electromyographic results obtained intrasurgically and knowledge of the presurgical assessment results. The laminae were replaced on the completion of the rootlet stimulation and secured with sutures in the yellow ligament and the supraspinous ligament.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• CP, spastic diplegia
• 4-7 years of age
• On Level IV-V 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
• Partial trunk control (sitting with support).

Exclusion Criteria

• Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
• Ankle clonus
• Exaggerated deep tendon reflex in the legs
• Babinski sign;
• Moderate to severe signs of dystonia, athetosis or ataxia.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mahmoud 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

Locations

Amira Mahmoud Abd-elmonem

Giza, , Egypt

Countries

Egypt

Other Identifiers

spastic cerebral palsy

Identifier Type: -

Identifier Source: org_study_id