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Completed

NCT Number: NCT02510222

Magnesium Therapy in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital, Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, 11381, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

Placebo

Other

Primary outcomes

  1. Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria

    Time frame: 1 month

Secondary outcomes

  1. Improvement in H/M ratio in H-reflex by electrophysiologic assessment

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2015
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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