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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04997044
• Other study ID #: selective dorsal rhizotomy
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Amira Mahmoud Abd-elmonem	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)