A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy (NCT05504798) | Clinical Trial Compass
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A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy
Egypt60 participantsStarted 2022-08-01
Plain-language 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.
Who can participate
Age range
3 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of knee and ankle passive range of motion (ROM)
Timeframe: At the beginning and after six weeks of intervention
2
Change of strength of knee extensors and ankle dorsiflexors muscles
Timeframe: At the beginning and after six weeks of intervention
3
Change of tone of hamstring and gastrocnemius muscles
Timeframe: At the beginning and after six weeks of intervention