Association Between Fatigue and Balance in Patients With Multiple Sclerosis

Imam Abdulrahman Bin Faisal University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Magnetic field; Device: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT04215354

IRB-2014-04-319

Details and patient eligibility

About

The relationship between fatigue and balance was established. Fatigue was correlated with 8 parameters of balance scales. Moreover, there was a strong correlation between the level of fatigue from one side and depression, quality of life and disease severity from the other side.Fatigue seems to be the main problem in patients with MS which may influence other signs and symptoms such as balance.

Full description

Electromagnetic field significantly reduced fatigue level in patients with MS.This effect reflected significantly on other symptoms such as balance, depression, disease severity and the quality of life in those patients.

Virtual reality program significantly improving balance and balance perception .Virtual reality program also improved quality of life by improving general health, physical function and decreasing physical limitation significantly. However, Virtual reality programs did not improve fatigue.

Enrollment: 95 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Relapsing remitting type of MS.
• Age between 20-50 years.
• Ambulatory with or without an device.
• Complaining of fatigue, Have a score of 4/10 or more on the fatigue visual analogue scale in last four weeks

Exclusion criteria

• An acute episode of MS within the last 30 days.
• Pregnancy at any stage.
• Severely blurred vision.
• A pacemaker.
• Epilepsy of any type.
• Recent organ transplant.
• Cardiac arrhythmia.
• Large aneurysm.
• Heavy psychosis.
• Otitis media in last 2 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 4 patient groups

MAGNET GROUP

Experimental group

Description:

Patients were exposed to very low pulsed electromagnetic field induced by BEMER machine model type: B.BOX Professional using magnet mattress.

Treatment:

Device: Magnetic field

VIRTUAL REALITY

Experimental group

Description:

Balance training was done using the Wii Fit plus machine which required balance board .Using video game console designed by Nintendo. The program consisted of three games: soccer heading, ski slalom and table tilt.

Treatment:

Device: Virtual reality

PLACEBO

Active Comparator group

Description:

Patients in the placebo group had identical program to magnet group. They were asked to lie down in the magnet mattress; however, the magnet was not switched on and the patient doesn't know (blind).

Treatment:

Device: Magnetic field

HEALTHY SUBJECT

No Intervention group

Description:

healthy subjects with age, gender and BMI matched with the patients with MS were recruited to participate in the study. This group was recruited to establish the normal balance and fatigue parameters. Subjects in this group sign the consent form of healthy subjects and all measurement was taken as balance, fatigue, depression, quality of life and urinary incontinence screening questionnaire.