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

Cairo University (CU)

Status: Completed

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

Treatments: Other: Three consecutive casts + Physical therapy program; Other: Physical therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT07338162

MD-97-2023

Details and patient eligibility

About

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).

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Other: Physical therapy program

Group B

Experimental group

Description:

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.

Treatment:

Other: Three consecutive casts + Physical therapy program