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

Not Applicable

• Conditions: Spastic Diplegic Cerebral Palsy
• Interventions: Other: Selected physical therapy program; Procedure: Interrupted serial casting; Device: Neuromuscular electrical stimulation

• Registration Number: NCT05504798
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-01
• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-04-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group (B)	Interrupted serial casting	will receive interrupted progressive serial casting in addition to a modified selected physical therapy program during casting.
Group (B)	Selected physical therapy program	will receive interrupted progressive serial casting in addition to a modified selected physical therapy program during casting.
Group (C)	Interrupted serial casting	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
Group (C)	Neuromuscular electrical stimulation	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
Group (A)	Selected physical therapy program	will receive a selected physical therapy program.
Group (C)	Selected physical therapy program	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

Primary Outcome Measures

Name	Time	Method
Change of knee and ankle passive range of motion (ROM)	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	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	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 Outcome Measures

Name	Time	Method
Change in sagittal kinematics parameters of gait pattern	At the beginning and after six weeks of intervention	The 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.

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Cairo, Egypt