NCT05006144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2025

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

August 7, 2021

Last Update Submit

April 23, 2026

Conditions

Bilateral Cerebral Palsy

Keywords

Bilateral Cerebral PalsySelective dorsal rhizotomysegmental trunk controlMotor development

Outcome Measures

Primary Outcomes (2)

  • 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.

    period of the treatment was 4 successive months

  • 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.

    period of the treatment was 4 successive months

Secondary Outcomes (1)

  • upper extremity function

    period of the treatment was 4 successive months

Study Arms (2)

control group

OTHER

control group

Other: physical therapy excercisesOther: Standard Orthotic Management

SDR-group

EXPERIMENTAL

selective dorsal rhizotomy

Other: physical therapy excercisesOther: Standard Orthotic ManagementOther: selective dorsal rhizotomy

Interventions

Standard Orthotic ManagementOTHER

A custom-made articulating ankle foot orthosis

SDR-groupcontrol group
physical therapy excercisesOTHER

* Sequenced trunk co-activation exercises * Righting and protective reactions * Functional stretching exercises.

SDR-groupcontrol group
selective dorsal rhizotomyOTHER

All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5

SDR-group

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • CP, spastic diplegia
  • years of age
  • On Level IV-V on Gross Motor Function Classification System
  • Partial trunk control (sitting with support).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Mahmoud Abd-elmonem

Giza, 12662, Egypt

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 16, 2021

Study Start

August 10, 2022

Primary Completion

January 30, 2024

Study Completion

December 24, 2025

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

EG(1)