Clinical trial NCT05242796: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Lead sponsor: King Fahad Armed Forces Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Imam Abdulrahman Bin Faisal University
First posted: 2022-02-16
Enrollment: 48
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized clinical trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline Modified Ashowreth Scale at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Gross Motor Function Scale at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Feet Contact Area at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Feet Maximum Force at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Change from baseline Cerebral Palsy Quality of Live Questionnaire (Family health dimension) at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Comparison of Modified Ashowreth Scale scores between the three groups from baseline at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Comparison of Gross Motor Function Scale scores between the three groups from baseline at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Comparison of Feet Contact Area scores between the three groups from baseline at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Comparison of Feet Maximum Force scores between the three groups from baseline at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: 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
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Comparison of Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
measure: 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
timeFrame: baseline, 4th week, 8th week and 12th week
measure: 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
timeFrame: baseline, 4th week, 8th week and 12th week
measure: 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
timeFrame: baseline, 4th week, 8th week and 12th week
measure: 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
timeFrame: baseline, 4th week, 8th week and 12th week
measure: Comparison of Cerebral Palsy Quality of Live Questionnaire (Family health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
timeFrame: baseline, 4th week, 8th week and 12th week
Secondary outcomes:
Other outcomes:
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