Magnesium Therapy in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Placebo; Dietary Supplement: Oral magnesium sulfate

• Registration Number: NCT02510222
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-26
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-29
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Fifty children with cerebral palsy will be treated with conventional therapy as physiotherapy. They will receive placebo.
Oral Magnesium sulfate	Oral magnesium sulfate	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

Primary Outcome Measures

Name	Time	Method
Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria	1 month

Secondary Outcome Measures

Name	Time	Method
Improvement in H/M ratio in H-reflex by electrophysiologic assessment	1 month

Trial Locations

Locations (1)

Children's Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt