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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spastic Diplegic Cerebral Palsy
• Intervention / Treatment: Other: Selected physical therapy program; Procedure: Interrupted serial casting; Device: Neuromuscular electrical stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group (A); will receive a selected physical therapy program.	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.
ACTIVE_COMPARATOR: Group (B); will receive interrupted progressive serial casting in addition to a modified selected physical therapy program during casting.	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.
ACTIVE_COMPARATOR: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (ACTUAL): August 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Diplegia, Neuromuscular electrical stimulation, Casting.
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: P.T.REC/012/003675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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