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

NCT ID: NCT07338162

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-02-01

Brief Summary

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).

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).

Conditions

Serial Casting; Management; Lower Limb Deformities; Spastic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physical therapy program

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Three consecutive casts + Physical therapy program

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abdou Mohamed Dawood

Orthopaedic Surgery specialist at Al-Helal Hospital, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-97-2023

Identifier Type: -

Identifier Source: org_study_id