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

A Randomized Controlled Study Investigating the Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Concomitant physical rehabilitation; Other: Standard Orthotic Management; Other: selective dorsal rhizotomy

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12662
    • Amira Mahmoud Abd-elmonem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group	Other: 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.; 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.
Experimental: Experimental group; selective dorsal rhizotomy group	Other: 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selective voluntary motor control	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.	after 6 months and after 1 year (follow-up)
Energy cost of walking	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).	after 6 months and after 1 year (follow-up)
Functional capacity	The six-minute walking test is used to assess walking capacity in children with and without disabilities.	after 6 months and after 1 year (follow-up)

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hazem A Aly, Phd, PhD of physical therapy for pediatrics, faculty of physical therapyCairo university; Study Director: Ahmed Rabie, Phd, Department of neurosurgery, faculty of medicine , Alexandria university; Principal Investigator: Sara S Saad-Eldien, PhD, Cairo university, faculty of physical therapy

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Functional capacity; Bilateral Cerebral Palsy; Selective dorsal rhizotomy; standard orthotic management; Functional balance; Energy Cost of Walking; Selective voluntary motor control:
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: selective dorsal rhizotomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No