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

Spastic Diplegic Cerebral Palsy Clinical Trial

Official title:

Efficacy of Neuromuscular Electrical Stimulation and Interrupted Serial Casting in Children With Spastic Diplegic Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504798
• Other study ID #: P.T.REC/012/003675
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2022
• Source: Cairo University
• Contact: Yasser M Abd Elmonem, MSC
• Phone: +201099259395
• Email: yasserelhawary131[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Diplegic Cerebral Palsy

Intervention

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

Procedure:
• 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.

Device:
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of knee and ankle passive range of motion (ROM)	Digital Goniometer will be used to measure the passive ROM of ankle dorsiflexion and the popliteal angle (PA)	At the beginning and after six weeks of intervention
Primary	Change of strength of knee extensors and ankle dorsiflexors muscles	Hand-held dynamometers (HHDs) " Lafayette manual muscle tester" (MMT) Will be used for quantitative assessment of maximal voluntary isometric contraction for knee extensors, and ankle dorsiflexors.	At the beginning and after six weeks of intervention
Primary	Change of tone of hamstring and gastrocnemius muscles	The Modified Tardieu Scale (MTS) will be used for analysis of dynamic spasticity of gastrocnemius and hamstring muscles. Measuring R1 (the fast velocity movement of the ankle or knee through the full ROM to determine the point of catch in the ROM), R2 (the passive ROM), and R2-R1 (dynamic component of spasticity).	At the beginning and after six weeks of intervention
Secondary	Change in sagittal kinematics parameters of gait pattern	The Observational Gait Scale (OGS) will be used for analysis of gait kinematics through 2 D videography with slow motion and split-screen video. Six sections will be tested to evaluate knee and ankle kinematics (Knee position in mid stance, Initial foot contact, Foot contact at mid stance, Base of support, Gait assistive devices, degree of change) with a total score of 17 on each limb. the minimum score is -2 and maximum score is 17. The higher scores mean a better outcome.	At the beginning and after six weeks of intervention