Back to resultsEffects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
Primary Purpose
Spastic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low frequency magnetic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
12 sessions of magnet
24 sessions of magnet
Placebo magnet intervention
Arm Description
Outcomes
Primary Outcome Measures
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
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.
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
Change from baseline Feet Maximum Force at 4, 8 and 12 weeks
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
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
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
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
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.
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.
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.
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.
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
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.
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
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
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
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
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
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05242796
First Posted
January 8, 2022
Last Updated
February 7, 2022
Sponsor
King Fahad Armed Forces Hospital
Collaborators
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT05242796
Brief Title
Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
Official Title
Placebo Controlled, Randomized, Double Blind, Clinical Trial of the Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
June 1, 2015 (Actual)
Study Completion Date
March 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Fahad Armed Forces Hospital
Collaborators
Imam Abdulrahman Bin Faisal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12 sessions of magnet
Arm Type
Experimental
Arm Title
24 sessions of magnet
Arm Type
Experimental
Arm Title
Placebo magnet intervention
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Low frequency magnetic therapy
Primary Outcome Measure Information:
Title
Change from baseline Modified Ashowreth Scale at 4, 8 and 12 weeks
Description
measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Gross Motor Function Scale at 4, 8 and 12 weeks
Description
to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Feet Contact Area at 4, 8 and 12 weeks
Description
The weight distribution between the feet and the ground - Higher grade means better outcome
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Feet Maximum Force at 4, 8 and 12 weeks
Description
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) at 4, 8 and 12 weeks
Description
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
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) at 4, 8 and 12 weeks
Description
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
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) at 4, 8 and 12 weeks
Description
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
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) at 4, 8 and 12 weeks
Description
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.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) at 4, 8 and 12 weeks
Description
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.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) at 4, 8 and 12 weeks
Description
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.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Family health dimension) at 4, 8 and 12 weeks
Description
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.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Comparison of Modified Ashowreth Scale scores between the three groups from baseline at 4, 8 and 12 weeks
Description
measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Comparison of Gross Motor Function Scale scores between the three groups from baseline at 4, 8 and 12 weeks
Description
to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Comparison of Feet Contact Area scores between the three groups from baseline at 4, 8 and 12 weeks
Description
The weight distribution between the feet and the ground - Higher grade means better outcome
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Comparison of Feet Maximum Force scores between the three groups from baseline at 4, 8 and 12 weeks
Description
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
Time Frame
baseline, 4th week, 8th week and 12th week
Title
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
Description
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
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Comparison of Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Description
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
Time Frame
baseline, 4th week, 8th week and 12th week
Title
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
Description
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
Time Frame
baseline, 4th week, 8th week and 12th week
Title
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
Description
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.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
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
Description
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.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
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
Description
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.
Time Frame
baseline, 4th week, 8th week and 12th week
Title
Comparison of Cerebral Palsy Quality of Live Questionnaire (Family health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Description
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.
Time Frame
baseline, 4th week, 8th week and 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
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