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

NCT04997044 | Completed

• 1 other identifier: selective dorsal rhizotomy
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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:

Outcome Measures

Primary Outcomes (2)

• Functional Balance

  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.

  after 6 months and after 1 year (follow-up)

• Gross motor function

  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.

  after 6 months and after 1 year (follow-up)

Secondary Outcomes (3)

• 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 Arms (2)

control group

OTHER

control group

Other: Concomitant physical rehabilitation; Other: Standard Orthotic Management

Experimental group

EXPERIMENTAL

selective dorsal rhizotomy group

Other: Concomitant physical rehabilitation; Other: Standard Orthotic Management; Other: selective dorsal rhizotomy

Interventions

Concomitant physical rehabilitation 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.

Experimental group; control group

Standard Orthotic Management 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; control group

selective dorsal rhizotomy 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.

Experimental group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• CP, spastic diplegia
• 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.
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amira Mahmoud Abd-elmonem

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hazem A Aly, Phd

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

  STUDY CHAIR

• Ahmed Rabie, Phd

  Department of neurosurgery, faculty of medicine , Alexandria university

  STUDY DIRECTOR

• Sara S Saad-Eldien, PhD

  Cairo university, faculty of physical therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 9, 2021
• Study Start: October 20, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

EG (1)