A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy

NCT ID: NCT05504798

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-08-01

Brief Summary

Combining the advantages of both Neuromuscular electrical stimulation and lower limb serial casting to a selected physical therapy program in children with spastic diplegic cerebral palsy to overcome the adverse effects during the period of casting and the long period of rehabilitative interventions, providing a new multimodal treatment approach.

Conditions

Spastic Diplegic Cerebral Palsy

Study Design

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

Study Groups

Group (A)

will receive a selected physical therapy program.

Group Type: ACTIVE_COMPARATOR

Selected physical therapy program

Intervention Type: OTHER

Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.

Group (B)

will receive interrupted progressive serial casting in addition to a modified selected physical therapy program during casting.

Group Type: ACTIVE_COMPARATOR

Selected physical therapy program

Intervention Type: OTHER

Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.

Interrupted serial casting

Intervention Type: PROCEDURE

Interrupted casting for 5 days a week for six successive weeks using a dual cast which consists of a standard short leg cast and a circular cast from below the knee to above the knee.

Group (C)

will receive interrupted progressive serial casting and the modified selected physical therapy as group (B) in addition to neuromuscular electrical stimulation for ankle dorsiflexors and knee extensors muscles through cast windows

Group Type: ACTIVE_COMPARATOR

Selected physical therapy program

Intervention Type: OTHER

Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.

Interrupted serial casting

Intervention Type: PROCEDURE

Interrupted casting for 5 days a week for six successive weeks using a dual cast which consists of a standard short leg cast and a circular cast from below the knee to above the knee.

Neuromuscular electrical stimulation

Intervention Type: DEVICE

Neuromuscular electrical stimulation in form of faradic current with frequency of 50 Hz, and intensity of maximum tolerable intensity to produce a visible contraction but as tolerated by the child for ankle dorsiflexors and knee extensors muscles through cast windows over the motor points of these muscles for 30 min 3 times weekly for six successive weeks

Interventions

Selected physical therapy program

Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.

Intervention Type: OTHER

Interrupted serial casting

Interrupted casting for 5 days a week for six successive weeks using a dual cast which consists of a standard short leg cast and a circular cast from below the knee to above the knee.

Intervention Type: PROCEDURE

Neuromuscular electrical stimulation

Neuromuscular electrical stimulation in form of faradic current with frequency of 50 Hz, and intensity of maximum tolerable intensity to produce a visible contraction but as tolerated by the child for ankle dorsiflexors and knee extensors muscles through cast windows over the motor points of these muscles for 30 min 3 times weekly for six successive weeks

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The children will have grade 2 or 3 on Modified Ashworth Scale.
• The children will have Level II, or III according to the Gross Motor Function Classification System.
• The children walk with equinus or jump gait patterns with spasticity of the hamstrings and hip flexors in addition to calf muscles spasticity.
• Children take their Antispastic drug use such as baclofen, diazepam or tizanidine.
• All children will be able to follow instructions.

Exclusion Criteria

• children will be excluded from the study if they have any problems of the following:

• Cognitive dysfunction.
• Poor skin integrity.
• History of or recent nonunion fracture.
• Fixed contractures and deformities.
• Previous surgery (tendon lengthening).
• Received Botulinum toxin A injections in the last six months.
• Impaired circulation.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasser Mamdouh Abd Elmonem Mohamed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yasser M Abd Elmonem, MSC

Role: CONTACT

yasserelhawary131@gmail.com

+201099259395

Facility Contacts

Yasser M Abd Elmonem, MSC

Role: primary

yasserelhawary131@gmail.com

+201099259395

Other Identifiers

P.T.REC/012/003675

Identifier Type: -

Identifier Source: org_study_id