Magnesium Therapy in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Effect of Magnesium Therapy on Spasticity and Constipation in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510222
• Other study ID #: Pediatrics MS
• Status: Completed
• Phase: N/A
• First received: July 26, 2015
• Last updated: February 9, 2017
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

• Age below12 years.

• Presence of spasticity without joint contracture Spasticity is defined as velocity dependent, increased resistance to passive muscle stretch.

• Acceptance of caregivers to participate in the study and signing the written consent.

• Constipation will be defined according to Rome lll criteria.presence of at least 2 of the following 2 motions week, history of painful or hard bowel movement, presence of large diameter stools that stools that may obstruct the toilets (Burgers et al., 2012).

Exclusion Criteria:

• Severe growth retardation (Below the 10th centile for weight and length charts children with cerebral palsy).

• Gastrostomy tube feeding.

• Joint contractures.

• Congenital malformations.

• Suspected inborn error of metabolism.

• Suspected inherited neurologic disease.

• Care giver's refusal to participate in the study.

• Occurrence of side effects of oral magnesium sulfate.

• Patients with cardiac, renal, GIT problem or chronic diarrhea.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Dietary Supplement:
• Oral magnesium sulfate
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 .

Other:
• Placebo

Locations

Country	Name	City	State
Egypt	Children's Hospital, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria		1 month
Secondary	Improvement in H/M ratio in H-reflex by electrophysiologic assessment		1 month

External Links

•   Faculty of Medicine, Ain Shams University