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

King Fahad Armed Forces Hospital

Status: Completed

Conditions: Spastic Cerebral Palsy

Treatments: Device: Low frequency magnetic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05242796

KFMMC

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

12 sessions of magnet

Experimental group

Treatment:

Device: Low frequency magnetic therapy

24 sessions of magnet

Experimental group

Treatment:

Device: Low frequency magnetic therapy

Placebo magnet intervention

Placebo Comparator group

Treatment:

Device: Low frequency magnetic therapy