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Completed

NCT Number: NCT05006144

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

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.

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Key information

Conditions

Bilateral Cerebral Palsy

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amira Mahmoud Abd-elmonem

Giza, 12662, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CP, spastic diplegia
  • 4-7 years of age
  • On Level IV-V on Gross Motor Function Classification System
  • 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.

Treatment and study plan

physical therapy excercises

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

Standard Orthotic Management

Other

A custom-made articulating ankle foot orthosis

selective dorsal rhizotomy

Other

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

Primary outcomes

  1. Segmental trunk control

    Time frame: period of the treatment was 4 successive months

    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.

  2. Gross motor function

    Time frame: period of the treatment was 4 successive months

    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.

Secondary outcomes

  1. upper extremity function

    Time frame: period of the treatment was 4 successive months

    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. T

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effects of Physical Training Following Selective Dorsal Rhizotomy on Trunk Control, Selectivity and Upper Extremity Function of Non-ambulant Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 16, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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