Back to resultsA New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy
Primary Purpose
Spastic Diplegic Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Selected physical therapy program
Interrupted serial casting
Neuromuscular electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Diplegic Cerebral Palsy focused on measuring Diplegia, Neuromuscular electrical stimulation, Casting.
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.
Sites / Locations
- Faculty of Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group (A)
Group (B)
Group (C)
Arm Description
will receive a selected physical therapy program.
will receive interrupted progressive serial casting in addition to a modified selected physical therapy program during 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
Outcomes
Primary Outcome Measures
Change of knee and ankle passive range of motion (ROM)
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
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
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
Change in sagittal kinematics parameters of gait pattern
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05504798
Brief Title
A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy
Official Title
Efficacy of Neuromuscular Electrical Stimulation and Interrupted Serial Casting in Children With Spastic Diplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Diplegic Cerebral Palsy
Keywords
Diplegia, Neuromuscular electrical stimulation, Casting.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (A)
Arm Type
Active Comparator
Arm Description
will receive a selected physical therapy program.
Arm Title
Group (B)
Arm Type
Active Comparator
Arm Description
will receive interrupted progressive serial casting in addition to a modified selected physical therapy program during casting.
Arm Title
Group (C)
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Selected physical therapy program
Intervention Description
Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.
Intervention Type
Procedure
Intervention Name(s)
Interrupted serial casting
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of knee and ankle passive range of motion (ROM)
Description
Digital Goniometer will be used to measure the passive ROM of ankle dorsiflexion and the popliteal angle (PA)
Time Frame
At the beginning and after six weeks of intervention
Title
Change of strength of knee extensors and ankle dorsiflexors muscles
Description
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.
Time Frame
At the beginning and after six weeks of intervention
Title
Change of tone of hamstring and gastrocnemius muscles
Description
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).
Time Frame
At the beginning and after six weeks of intervention
Secondary Outcome Measure Information:
Title
Change in sagittal kinematics parameters of gait pattern
Description
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.
Time Frame
At the beginning and after six weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser M Abd Elmonem, MSC
Phone
+201099259395
Email
yasserelhawary131@gmail.com
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasser M Abd Elmonem, MSC
Phone
+201099259395
Email
yasserelhawary131@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy
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