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

NCT ID: NCT05242796

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-01
• Study Completion Date: 2016-03-01

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.

Conditions

Spastic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

12 sessions of magnet

Group Type: EXPERIMENTAL

Low frequency magnetic therapy

Intervention Type: DEVICE

24 sessions of magnet

Group Type: EXPERIMENTAL

Low frequency magnetic therapy

Intervention Type: DEVICE

Placebo magnet intervention

Group Type: PLACEBO_COMPARATOR

Low frequency magnetic therapy

Intervention Type: DEVICE

Interventions

Low frequency magnetic therapy

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role: collaborator

King Fahad Armed Forces Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ali AlGhamdi

Sr. Physical Therapy Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KFMMC

Identifier Type: -

Identifier Source: org_study_id