Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy

Placebo Controlled, Randomized, Double Blind, Clinical Trial of the Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy

Background: Spasticity is a major challenge in patients with cerebral palsy (CP). It may cause unwanted complications and may affect the patient's quality of life. Currently there is no satisfactory long lasting control of spasticity. Many lines of evidence indicate that magnet therapy may be a useful intervention in the management of spasticity. Several studies showed that magnet may inhibit neuronal firing in the human nervous system; however, its effects weren't studied on spasticity. Objectives: The goal of the present study was to determine the short-and long-term effects of pulsed low frequency magnetic field therapy on spasticity in patient with CP. Methods: 48 patients with CP, who have measureable level of spasticity, were selected. The sample was divided randomly into active magnet group (received magnet therapy, 32 subjects) and placebo group (16 subjects). At the end of the 4th week the magnet group was divided into two sub-groups: 1st sub-group received magnet therapy for another 4 weeks while the other received the placebo. Measurements was taken at baseline, 4th, 8th and 12th weeks. Modified Ashworth Scale was used to measure spasticity, foot pressure platform system was used to measure the contact area and the maximum force of the feet, gross motor function measure (GMFM) was used to measure the functional level of the patients. The cerebral palsy quality of life (CP-QoL) questionnaire was used to measure the patients' various dimensions of quality of life.

Study Overview

• Status: Completed
• Conditions: Spastic Cerebral Palsy
• Intervention / Treatment: Device: Low frequency magnetic therapy

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A confirmed diagnosis of diplegic or quadriplegic CP of both genders,
• Able to stand without assistance.
• Age from 4-16 years
• Measureable spasticity (1 or more according to the Modified Ashworth Scale).

Exclusion Criteria:

• Have recent organ transplants.
• Have heart pace maker.
• Have cardiac arrhythmia, tachy cardiac conditions or large aneurysm.
• Have heavy psychosis.
• Underwent any neuromuscular blockers of Spasticity.
• Underwent any surgery of tendon lengthening before or during the study.
• Have epileptic episodes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 12 sessions of magnet	Device: Low frequency magnetic therapy
EXPERIMENTAL: 24 sessions of magnet	Device: Low frequency magnetic therapy
PLACEBO_COMPARATOR: Placebo magnet intervention	Device: Low frequency magnetic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Modified Ashowreth Scale at 4, 8 and 12 weeks	measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome	baseline, 4th week, 8th week and 12th week
Change from baseline Gross Motor Function Scale at 4, 8 and 12 weeks	to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.	baseline, 4th week, 8th week and 12th week
Change from baseline Feet Contact Area at 4, 8 and 12 weeks	The weight distribution between the feet and the ground - Higher grade means better outcome	baseline, 4th week, 8th week and 12th week
Change from baseline Feet Maximum Force at 4, 8 and 12 weeks	Measuring Feet Maximum Force of the participants - Higher grade means better outcome	baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) at 4, 8 and 12 weeks	Items numbers in the questionnaire: (1,3,4,5,6,7,10,11,12,13,14,15).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome	baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) at 4, 8 and 12 weeks	Items numbers in the questionnaire: (8,22,23,24,27,29,34,35,37,38,39,40).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome	baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) at 4, 8 and 12 weeks	Items numbers in the questionnaire: (9,16,17,18,19,20,21,25,26,30,37).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome	baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) at 4, 8 and 12 weeks	Items numbers in the questionnaire: (2,28,31,32,33,52).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome.	baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) at 4, 8 and 12 weeks	Items numbers in the questionnaire: (41, 42, 43, 53, 54, 55, 56, 57, 58, 59, 60, 61).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome.	baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) at 4, 8 and 12 weeks	Items numbers in the questionnaire: (44, 45, 46, 47, 48, 49, 50, 51).; Each item has an answer from one to nine; where (1= not bothered at all) to (9 = very bothered).; To be calculated by summation of all the dimension's score.; Higher score means worse outcome.	baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Family health dimension) at 4, 8 and 12 weeks	Items numbers in the questionnaire: (62, 63, 64, 65).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome.	baseline, 4th week, 8th week and 12th week
Comparison of Modified Ashowreth Scale scores between the three groups from baseline at 4, 8 and 12 weeks	measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome	baseline, 4th week, 8th week and 12th week
Comparison of Gross Motor Function Scale scores between the three groups from baseline at 4, 8 and 12 weeks	to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.	baseline, 4th week, 8th week and 12th week
Comparison of Feet Contact Area scores between the three groups from baseline at 4, 8 and 12 weeks	The weight distribution between the feet and the ground - Higher grade means better outcome	baseline, 4th week, 8th week and 12th week
Comparison of Feet Maximum Force scores between the three groups from baseline at 4, 8 and 12 weeks	Measuring Feet Maximum Force of the participants - Higher grade means better outcome	baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) scores between the three groups from baseline at 4, 8 and 12 weeks	Items numbers in the questionnaire: (1,3,4,5,6,7,10,11,12,13,14,15).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome	baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) scores between the three groups from baseline at 4, 8 and 12 weeks	Items numbers in the questionnaire: (8,22,23,24,27,29,34,35,37,38,39,40).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome	baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks	Items numbers in the questionnaire: (9,16,17,18,19,20,21,25,26,30,37).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome	baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) scores between the three groups from baseline at 4, 8 and 12 weeks	Items numbers in the questionnaire: (2,28,31,32,33,52).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome.	baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) scores between the three groups from baseline at 4, 8 and 12 weeks	Items numbers in the questionnaire: (41, 42, 43, 53, 54, 55, 56, 57, 58, 59, 60, 61).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome.	baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) scores between the three groups from baseline at 4, 8 and 12 weeks	Items numbers in the questionnaire: (44, 45, 46, 47, 48, 49, 50, 51).; Each item has an answer from one to nine; where (1= not bothered at all) to (9 = very bothered).; To be calculated by summation of all the dimension's score.; Higher score means worse outcome.	baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Family health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks	Items numbers in the questionnaire: (62, 63, 64, 65).; Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.; To be calculated by summation of all the dimension's score.; Higher score means better outcome.	baseline, 4th week, 8th week and 12th week

Collaborators and Investigators

• Sponsor: King Fahad Armed Forces Hospital
• Collaborators: Imam Abdulrahman Bin Faisal University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: January 8, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (ACTUAL): February 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: KFMMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No