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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05504798
Enrollment
60
Registered
2022-08-17
Start date
2022-08-01
Completion date
2023-08-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Diplegic Cerebral Palsy

Keywords

Diplegia, Neuromuscular electrical stimulation, Casting.

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.

Interventions

OTHERSelected physical therapy program

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

PROCEDUREInterrupted 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.

DEVICENeuromuscular 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of knee and ankle passive range of motion (ROM)At the beginning and after six weeks of interventionDigital Goniometer will be used to measure the passive ROM of ankle dorsiflexion and the popliteal angle (PA)
Change of strength of knee extensors and ankle dorsiflexors musclesAt the beginning and after six weeks of interventionHand-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.
Change of tone of hamstring and gastrocnemius musclesAt the beginning and after six weeks of interventionThe 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).

Secondary

MeasureTime frameDescription
Change in sagittal kinematics parameters of gait patternAt the beginning and after six weeks of interventionThe 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.

Countries

Egypt

Contacts

Primary ContactYasser M Abd Elmonem, MSC
yasserelhawary131@gmail.com+201099259395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026