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

Spastic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242796
• Other study ID #: KFMMC
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: March 1, 2016

Study information

• Verified date: February 2022
• Source: King Fahad Armed Forces Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 1, 2016
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Spastic Cerebral Palsy

Intervention

Device:
• Low frequency magnetic therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
King Fahad Armed Forces Hospital	Imam Abdulrahman Bin Faisal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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