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NCT Number: NCT07338162

Is Serial Casting a Valid Option for Management of Lower Limb Deformities in Patient With Spastic Cerebral Palsy?

This study aimed to evaluate the effectiveness of serial casting as a modality of management of lower limb deformities in patients with spastic cerebral palsy (equinous - equinovarus).

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Key information

Conditions

Serial Casting Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Lower Limb Deformities Management Nervous System Diseases Spastic Cerebral Palsy

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

About this study

Cerebral Palsy (CP) is classified as a group of postural and motor disorders caused by a non-progressive lesion to the developing brain, acquired before the age of two. Among the different types of CP, spastic CP is the most common form consisting of approximately 85.8% of diagnoses.

Current clinical management of spasticity and contracture in the lower limb includes conservative approaches such as the use of physiotherapy, orthoses, casting and splinting. Other commonly used invasive strategies for spasticity and contracture management include neurotoxin injections such as botulinum toxin A (BTX-A) and intrathecal baclofen, as well as surgery such as selective dorsal rhizotomy (SDR) and various corrective orthopaedic operations including tendon lengthening procedures and single-event multilevel surgeries (SEMLS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients from 3 to 12 years old.
  • Both sex.
  • Spastic cerebral palsy patients with true equinous.
  • Modified Ashworth Scale score of 2 or 3 in the plantar flexor muscle complex.
  • Gross Motor Functional Classification System Level I, II & III.

Exclusion criteria

  • Patients with bony joint limitation.
  • Previous surgeries (tendon lengthening).
  • Patients received Botulinum toxin A injections in the last six months.
  • Patients with apparent equinus as a compensation for knee or hip flexion while dorsiflexion range is preserved at the lower extremity.

Treatment and study plan

physical therapy program

Other

Children with spastic cerebral palsy who is subjected to a selected physical therapy program once a day/3 times a week for three successive weeks mainly consisted of stretching and strengthening exercises, weight bearing, balance, proprioception, and ambulation training.

Three consecutive casts + Physical therapy program

Other

Children with spastic cerebral palsy who is additionally subjected to three consecutive casts applied for five days each and will be removed in the last two days in each week to conduct the same selected physical therapy program.

Primary outcomes

  1. Evaluation of ankle range of motion

    Time frame: 3 months after the procedure

    Ankle range of motion was assessed.

Secondary outcomes

  1. Tone of the calf muscle

    Time frame: 3 months after the procedure

    Tone of the calf muscle was measured.

  2. Detection of ankle kinematics during gait

    Time frame: 3 months after the procedure

    The children will be instructed to walk and videos were taken from the side, only five sections were tested to evaluate ankle kinematics and knee position in relation to ankle (initial foot contact, foot contact at mid stance, timing of heel rise, knee position in mid stance, degree of change) with a total score of 14 on each limb.

  3. Incidence of true equinous in patients with spastic cerebral palsy

    Time frame: 3 months after the procedure

    Incidence of true equinous in patients with spastic cerebral palsy was assessed.

  4. Modified Ashworth Scale (MAS) score

    Time frame: 3 months after the procedure

    The Modified Ashworth Scale (MAS) score is a widely used measurement tool, and it is scored as follows: 0, no increase in muscle tone; 1, slight increase in muscle tone at the end of the range of motion; 2, slight increase in muscle tone through less than half of the range of motion; 3, more marked increase in muscle tone through most of the range of motion; 4, considerable increase in muscle tone; and 5, joint is rigid.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Is Serial Casting a Valid Option for Management of Lower Limb Deformities in Patient With Spastic Cerebral Palsy (Equinus - Equinovarus)?

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2026
Registry last updated
Jan 13, 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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