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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spastic Cerebral Palsy

Intervention / Treatment
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* Device: Low frequency magnetic therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 sessions of magnet<br> | Device: Low frequency magnetic therapy<br> <br> |
| Experimental: 24 sessions of magnet<br> | Device: Low frequency magnetic therapy<br> <br> |
| Placebo Comparator: Placebo magnet intervention<br> | Device: Low frequency magnetic therapy<br> <br> |

What is the study measuring?
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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 |