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

Cairo University (CU)

Status: Enrolling

Conditions: Spastic Diplegic Cerebral Palsy

Treatments: Device: Neuromuscular electrical stimulation; Procedure: Interrupted serial casting; Other: Selected physical therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT05504798

P.T.REC/012/003675

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group (A)

Active Comparator group

Description:

will receive a selected physical therapy program.

Treatment:

Other: Selected physical therapy program

Group (B)

Active Comparator group

Description:

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

Treatment:

Other: Selected physical therapy program

Procedure: Interrupted serial casting

Group (C)

Active Comparator group

Description:

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

Treatment:

Other: Selected physical therapy program

Procedure: Interrupted serial casting

Device: Neuromuscular electrical stimulation