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

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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

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

Trial contacts and locations

0

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Central trial contact

Yasser M Abd Elmonem, MSC

Data sourced from clinicaltrials.gov

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