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

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

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).

Study Overview

• Status: Completed
• Conditions: Spastic Cerebral Palsy; Management; Serial Casting; Lower Limb Deformities
• Intervention / Treatment: Other: Physical therapy program; Other: Three consecutive casts + Physical therapy program

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 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.	Other: Physical therapy program; 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.
Experimental: Group B; 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.	Other: Three consecutive casts + Physical therapy program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of ankle range of motion	Ankle range of motion was assessed.	3 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tone of the calf muscle	Tone of the calf muscle was measured.	3 months after the procedure
Detection of ankle kinematics during gait	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 months after the procedure
Incidence of true equinous in patients with spastic cerebral palsy	Incidence of true equinous in patients with spastic cerebral palsy was assessed.	3 months after the procedure
Modified Ashworth Scale (MAS) score	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.	3 months after the procedure

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: MD-97-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No