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Completed

NCT Number: NCT04997044

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amira Mahmoud Abd-elmonem

Giza, 12662, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Concomitant physical rehabilitation

Other

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

Other

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

Other

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.

Primary outcomes

  1. Functional Balance

    Time frame: after 6 months and after 1 year (follow-up)

    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.

  2. Gross motor function

    Time frame: after 6 months and after 1 year (follow-up)

    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.

Secondary outcomes

  1. Selective voluntary motor control

    Time frame: after 6 months and after 1 year (follow-up)

    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.

  2. Energy cost of walking

    Time frame: 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).

  3. Functional capacity

    Time frame: after 6 months and after 1 year (follow-up)

    The six-minute walking test is used to assess walking capacity in children with and without disabilities.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2021
Registry last updated
Dec 7, 2022

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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