Spastic Diplegic Cerebral PalsyNCT05504798
A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy
A study testing Selected physical therapy program, Interrupted serial casting and Neuromuscular electrical stimulation in people with Spastic Diplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- Selected physical therapy program, Interrupted serial casting and Neuromuscular electrical stimulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Cairo
Yasser M Abd Elmonem, MSC, +201099259395, yasserelhawary131@gmail.com
About this study
Official title: Efficacy of Neuromuscular Electrical Stimulation and Interrupted Serial Casting in Children With Spastic Diplegic Cerebral Palsy
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.
- Conditions
- Spastic Diplegic Cerebral Palsy
- Being tested
- Selected physical therapy program, Interrupted serial casting, Neuromuscular electrical stimulation
- Keywords
- Diplegia, Neuromuscular electrical stimulation, Casting.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected physical therapy programOther
Selected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training.
Interrupted serial castingProcedure or surgery
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.
Neuromuscular electrical stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | will receive a selected physical therapy program. Receives: Other: Selected physical therapy program |
| Group (B) | Active comparator | will receive interrupted progressive serial casting in addition to a modified selected physical therapy program during casting. Receives: Other: Selected physical therapy program; Procedure: Interrupted serial casting |
| Group (C) | Active comparator | 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 Receives: Other: Selected physical therapy program; Procedure: Interrupted serial casting; Device: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the beginning and after six weeks of intervention
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.
Measured: At the beginning and after six weeks of intervention
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).
Measured: At the beginning and after six weeks of intervention
Secondary outcomes (1)
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.
Measured: At the beginning and after six weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mamdouh Abd Elmonem Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504798
- Sponsor's protocol ID
- P.T.REC/012/003675
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neuromuscular Electrical Stimulation and Interrupted Serial Casting in Children With Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05504798
- Acronym / sponsor ID
- P.T.REC/012/003675
- Conditions
- Spastic Diplegic Cerebral Palsy
- Keywords
- Diplegia, Neuromuscular electrical stimulation, Casting.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Other: Selected physical therapy programwill receive a selected physical therapy program. |
| Group (B) | Active comparator | Other: Selected physical therapy program, Procedure: Interrupted serial castingwill receive interrupted progressive serial casting in addition to a modified selected physical therapy program during casting. |
| Group (C) | Active comparator | Other: Selected physical therapy program, Procedure: Interrupted serial casting, Device: Neuromuscular electrical stimulationwill 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 |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- children will be excluded from the study if they have any problems of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selected physical therapy programSelected physical therapy program one hour three times weekly for six successive weeks including stretching, strengthening, balance, and gait training. | Other | Group (A), Group (B), Group (C) |
| Interrupted serial castingInterrupted 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. | Procedure or surgery | Group (B), Group (C) |
| Neuromuscular electrical stimulationNeuromuscular 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 | Device | Group (C) |
Primary outcome
Change of knee and ankle passive range of motion (ROM)
Time frame: 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
Time frame: 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
Time frame: 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).
1 secondary outcome
Change in sagittal kinematics parameters of gait pattern
Time frame: At the beginning and after six weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selected physical therapy program, Interrupted serial casting and Neuromuscular electrical stimulation in people with Spastic Diplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasser M Abd Elmonem, MSC (+201099259395, yasserelhawary131@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of knee and ankle passive range of motion (ROM) (time frame: At the beginning and after six weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.