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

Primary Purpose

Bilateral Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sequenced trunk co-activation exercises
Standard Orthotic Management
selective dorsal rhizotomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Cerebral Palsy focused on measuring Bilateral Cerebral Palsy, Selective dorsal rhizotomy, segmental trunk control, Motor development

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amira Mahmoud Abd-elmonem

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control group

Experimental group

Arm Description

control group

selective dorsal rhizotomy

Outcomes

Primary Outcome Measures

Segmental trunk control
The Segmental Assessment of Trunk Control is applied to assess upright trunk postural control in sitting position based on subdividing the trunk into 6 segments. The head/trunk control is acquired segment by segment if upright sitting posture can be maintained under three conditions including: static control at static position, active control while the child moves the head and/or arm and reactive control after external perturbation.The trunk segments according to the scale include: head/neck, thoracic (upper, mid and lower) and lumbar (upper and lower) segments. It is an ordinal scale with a grade 1 to 7 is assigned for each segment with the score 7 indicates that the infant can't retain independent sitting (no hand support). A score of 8 is given as full trunk control is gained.
Gross motor function
The gross motor function measure-88 is a valid and reliable criterion referenced instrument; is currently used to evaluate the motor function over time in individuals with cerebral palsy. It 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. The scoring key was; 0=does not initiate, 1=initiates the task (<10%), 2=partial completion of the task (10% to <100%), 3=task completed (100%). If an item was not tested it was marked as not tested

Secondary Outcome Measures

upper extremity function
The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy ages of 18 months to 8 years. The assessment procedures were conducted according to the instruction manual to assess the movement patterns in four basic domains representing dissociated movement; grasp; protective extension; and weight bearing. The total scores for each domain percentage score are calculated as total score which range from zero to 100% with higher score reflects better performance.

Full Information

First Posted
August 7, 2021
Last Updated
December 6, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05006144
Brief Title
Effects of Selective Dorsal Rhizotomy on Non-ambulant Children With Bilateral Spastic Cerebral Palsy
Official Title
Effects of Selective Dorsal Rhizotomy on Trunk Control, Selectivity and Upper Extremity Function of Non-ambulant Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Cerebral Palsy
Keywords
Bilateral Cerebral Palsy, Selective dorsal rhizotomy, segmental trunk control, Motor development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Random allocation of participants will be completed using a random number generator, with the allocation to either the control or selective dorsal rhizotomy group being concealed. The random numbers are generated by the principle physical therapists with every alternate number being marked either "1" or "2." However, the receptionist was blinded to the interventions assigned to group 1 (control group) and group 2 (SDR group). During allocation, every parent/legal guardian is asked to pick up one enclosed envelope from a box containing numbers from 1 to 30. Then, they are allocated to either group 1 or group 2 to minimize the risk of allocation bias.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
control group
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
selective dorsal rhizotomy
Intervention Type
Other
Intervention Name(s)
sequenced trunk co-activation exercises
Intervention Description
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
Intervention Name(s)
Standard Orthotic Management
Intervention Description
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
Intervention Name(s)
selective dorsal rhizotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Segmental trunk control
Description
The Segmental Assessment of Trunk Control is applied to assess upright trunk postural control in sitting position based on subdividing the trunk into 6 segments. The head/trunk control is acquired segment by segment if upright sitting posture can be maintained under three conditions including: static control at static position, active control while the child moves the head and/or arm and reactive control after external perturbation.The trunk segments according to the scale include: head/neck, thoracic (upper, mid and lower) and lumbar (upper and lower) segments. It is an ordinal scale with a grade 1 to 7 is assigned for each segment with the score 7 indicates that the infant can't retain independent sitting (no hand support). A score of 8 is given as full trunk control is gained.
Time Frame
period of the treatment was 4 successive months
Title
Gross motor function
Description
The gross motor function measure-88 is a valid and reliable criterion referenced instrument; is currently used to evaluate the motor function over time in individuals with cerebral palsy. It 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. The scoring key was; 0=does not initiate, 1=initiates the task (<10%), 2=partial completion of the task (10% to <100%), 3=task completed (100%). If an item was not tested it was marked as not tested
Time Frame
period of the treatment was 4 successive months
Secondary Outcome Measure Information:
Title
upper extremity function
Description
The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy ages of 18 months to 8 years. The assessment procedures were conducted according to the instruction manual to assess the movement patterns in four basic domains representing dissociated movement; grasp; protective extension; and weight bearing. The total scores for each domain percentage score are calculated as total score which range from zero to 100% with higher score reflects better performance.
Time Frame
period of the treatment was 4 successive months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem A Aly, Phd
Organizational Affiliation
PhD of physical therapy for pediatrics, faculty of physical therapyCairo university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed rabie, Phd
Organizational Affiliation
Department of neurosurgery, faculty of medicine , Alexandria university
Official's Role
Study Director
Facility Information:
Facility Name
Amira Mahmoud Abd-elmonem
City
Giza
ZIP/Postal Code
12662
Country
Egypt

12. IPD Sharing Statement

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

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