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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05504798

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spastic Diplegic Cerebral Palsy	Other: Selected physical therapy program Procedure: Interrupted serial casting Device: Neuromuscular electrical stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group (A) will receive a selected physical therapy program.	Other: Selected physical therapy program Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.
Active Comparator: Group (B) will receive interrupted progressive serial casting in addition to a modified selected physical therapy program during casting.	Other: Selected physical therapy program Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training. Procedure: Interrupted serial casting 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.
Active Comparator: Group (C) 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	Other: Selected physical therapy program Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training. Procedure: Interrupted serial casting 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. Device: Neuromuscular electrical stimulation 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

Arm

Intervention/Treatment

Active Comparator: Group (A)

will receive a selected physical therapy program.

Other: Selected physical therapy program

Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.

Active Comparator: Group (B)

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

Other: Selected physical therapy program

Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.

Procedure: Interrupted serial casting

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.

Active Comparator: Group (C)

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

Other: Selected physical therapy program

Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.

Procedure: Interrupted serial casting

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.

Device: Neuromuscular electrical stimulation

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 7 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Physical Therapy	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasser Mamdouh Abd Elmonem Mohamed, Principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05504798

Other Study ID Numbers:

P.T.REC/012/003675

First Posted:

Aug 17, 2022

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yasser Mamdouh Abd Elmonem Mohamed, Principal investigator, Cairo University

Diplegia, Neuromuscular electrical stimulation, Casting.

Additional relevant MeSH terms:

Muscle Spasticity

Cerebral Palsy

Study Results

No Results Posted as of Aug 17, 2022