Efficacy of Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04997044
Collaborator
(none)
42
1
2
27.3
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Concomitant physical rehabilitation
  • Other: Standard Orthotic Management
  • Other: selective dorsal rhizotomy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Study Investigating the Efficacy of Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia
Actual Study Start Date :
Nov 20, 2019
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: control group

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.

Outcome Measures

Primary Outcome Measures

  1. Functional Balance [after 6 months and after 1 year (follow-up)]

    The pediatric balance scale was used to assess the child's functional performance in 3 dimensions representing sitting, standing, and postural change activities. It comprises a 14-items; each item was graded from 0 to 4 points giving a maximum total score 56 points, with a higher score representing a better performance.

  2. Gross motor function [after 6 months and after 1 year (follow-up)]

    The gross motor function measure-88 is a valid and reliable instrument currently used to evaluate the motor function over time in individuals with CP and consists of 5 sections including; A) lying and rolling, B) sitting, C) crawling and kneeling, D) standing; E) walking, running, jumping. Each item was scored on a four-point scale as 0, 1, 2 or 3 with higher scores representing a better performance.

Secondary Outcome Measures

  1. Selective voluntary motor control: [after 6 months and after 1 year (follow-up)]

    It is a valid and reliable tool frequently used for assessment of isolated movements of the lower limb joints in children with spastic cerebral palsy with a maximum score of 20 points, 10 points for each limb.

  2. Energy cost of walking [after 6 months and after 1 year (follow-up)]

    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). the resting heart rate will be obtained for each child during comfortable sitting position for 5 minutes by using pulse oximeter. Walking heart rate and speed will be obtained immediately following a walking test (with a comfortable speed) for duration of 5 minutes in a walkway.

  3. Functional capacity [after 6 months and after 1 year (follow-up)]

    The six-minute walking test is a reliable and valid measure of submaximal exercise capacity in children with and without disabilities. Children are instructed to walk around a marked hallway, 20 meters in length, as fast as possible for 6 minutes at a self-chosen walking speed. The time was recorded with a stopwatch. The total distance covered was measured in meters.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amira Mahmoud Abd-elmonem Giza Egypt 12662

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amira Mahmoud Abd-elmonem, Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university, Cairo University
ClinicalTrials.gov Identifier:
NCT04997044
Other Study ID Numbers:
  • selective dorsal rhizotomy
First Posted:
Aug 9, 2021
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amira Mahmoud Abd-elmonem, Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022