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

NCT05504798 | Unknown

• 1 other identifier: P.T.REC/012/003675
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Diplegia, Neuromuscular electrical stimulation, Casting.

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in sagittal kinematics parameters of gait pattern

  At the beginning and after six weeks of intervention

Study Arms (3)

Group (A)

ACTIVE COMPARATOR

will receive a selected physical therapy program.

Other: Selected physical therapy program

Group (B)

ACTIVE COMPARATOR

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

Other: Selected physical therapy program; Procedure: Interrupted serial casting

Group (C)

ACTIVE COMPARATOR

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; Procedure: Interrupted serial casting; Device: Neuromuscular electrical stimulation

Interventions

Selected physical therapy program OTHER

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

Group (A); Group (B); Group (C)

Interrupted serial casting 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 (B); Group (C)

Neuromuscular electrical stimulation 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

Group (C)

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Yasser M Abd Elmonem, MSC

CONTACT

+201099259395; yasserelhawary131@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: August 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)