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Magnesium Therapy in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oral magnesium sulfate
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring child

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Magnesium sulfate

Control

Arm Description

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

Fifty children with cerebral palsy will be treated with conventional therapy as physiotherapy. They will receive placebo.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2015
Last Updated
February 9, 2017
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02510222
Brief Title
Magnesium Therapy in Children With Cerebral Palsy
Official Title
Effect of Magnesium Therapy on Spasticity and Constipation in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Magnesium sulfate
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Fifty children with cerebral palsy will be treated with conventional therapy as physiotherapy. They will receive placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral magnesium sulfate
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Improvement in H/M ratio in H-reflex by electrophysiologic assessment
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar MA Hassanein, PhD, MD
Organizational Affiliation
Pediatric department, Faculty of Medicine , Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11381
Country
Egypt

12. IPD Sharing Statement

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Magnesium Therapy in Children With Cerebral Palsy

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