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Clinical Trials/NCT05504798
NCT05504798
Unknown
Not Applicable

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

Cairo University1 site in 1 country60 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spastic Diplegic Cerebral Palsy
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Change of knee and ankle passive range of motion (ROM)
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
August 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yasser Mamdouh Abd Elmonem Mohamed

Principal investigator

Cairo University

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.

Outcomes

Primary Outcomes

Change of knee and ankle passive range of motion (ROM)

Time Frame: At the beginning and after six weeks of intervention

Digital 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 muscles

Time Frame: At the beginning and after six weeks of intervention

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.

Change of tone of hamstring and gastrocnemius muscles

Time Frame: At the beginning and after six weeks of intervention

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).

Secondary Outcomes

  • Change in sagittal kinematics parameters of gait pattern(At the beginning and after six weeks of intervention)

Study Sites (1)

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