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This study is considered a pilot exploratory study. Intervention, prospective, double-armed, randomized, placebo-control clinical trial.
The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be studied.
Spasticity and constipation are major problems hindering improvement in motor development in children with cerebral palsy.
Decreasing spasticity will have a positive effect on motor development and quality of life for the child and his family.
The aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on spasticity and constipation in infants and children with cerebral palsy.
Hundred children with spastic cerebral palsy will be randomized to either intervention group n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and constipation in addition to their conventional treatment, or placebo group n=50 will receive conventional treatment and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Magnesium sulfate | Experimental | Magnesium sulphate 4% concentration orally ( 65 mg per day for children one to three years of age; 110 mg per day for children four to eight years of age; 350 mg per day for children older than eight years) for 1 month |
|
| Control | Placebo Comparator | Fifty children with cerebral palsy will be treated with conventional therapy as physiotherapy. They will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral magnesium sulfate | Dietary Supplement | Magnesium sulfate 4% concentration in a dose of 65 mg/day for infants and children aged 1-3 years , 110 mg/day for those 3-8 years and 350 mg/day for those above 9 years .Each 1 ml of the magnesium sulfate used contains 0.325 mEq (milliequivalent) of elemental magnesium which equals to 4 mg elemental magnesium . |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in H/M ratio in H-reflex by electrophysiologic assessment | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sahar MA Hassanein, PhD, MD | Pediatric department, Faculty of Medicine , Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Faculty of Medicine, Ain Shams University | Cairo | Cairo Governorate | 11381 | Egypt |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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|
| Placebo | Other |
|
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |