Association Between Fatigue and Balance in Patients With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Device: Magnetic fieldDevice: Virtual reality
- Registration Number
- NCT04215354
- Lead Sponsor
- Imam Abdulrahman Bin Faisal University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MAGNET GROUP Magnetic field Patients were exposed to very low pulsed electromagnetic field induced by BEMER machine model type: B.BOX Professional using magnet mattress. VIRTUAL REALITY Virtual reality 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. PLACEBO Magnetic field 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).
- Primary Outcome Measures
Name Time Method Depression (Beck depression inventory ii (BDI-II)) 12 weeks. It is 21 questions with each item range from 0 (normal) to 3 (most severe) with a maximum score of 63 (worse condition).The total score of the scale was used to classify patients as follows: normal (1-10), mild mood disturbance (11-16), border line of depression (17-20), moderate depression (21-30), severe depression (31-40), extreme depression (over 40)
balance confidence 12 weeks. Activities- specific Balance Confidence scale .it is 16 items ofvisual analogue scale from 0-100%.score from 0 minimum confidence (worse condition) to 1600 maximum score (better condition).
Modified Fatigue Impact Scale 12 weeks. It is a 21 items standardized questionnaire. Each item has five levels of response (range from 0 - 4). The total score ranges from 0 (no impact of fatigue) better condition to 84 (maximum impact of fatigue)worse condition.
Balance 12 weeks. Berg Balance Scale (BBS)range from 0(worse condition) to 56(better condition)
Static balance using posturography, 12 weeks stability levels range from 1 to 10, with 10 being the most stable or least difficult to perform. Static balance was measured at three different levels of stability; high level 8, medium 5 and low level 2. These levels where chosen to test patient balance on varying degree of instability.Patient who was unable to do the test due to sever balance impairment was given a score of 5000 based on the manufacturer recommendations in the machine manual (maximum score can subject got) which mean sever imbalance.
- Secondary Outcome Measures
Name Time Method Quality of life measurement (Short Form 36 (SF-36) 12 weeks. The SF-36 consists of eight scaled scores as vitality (energy/fatigue), physical functioning, bodily pain, general health perceptions, and physical role functioning, emotional role functioning, social role functioning and mental health.each item is scored from 0-100 for total 1800. The lower the score the more the disability. The higher the score the less disability.
Trial Locations
- Locations (1)
Imam Abdulrahman Bin Faisal University
🇸🇦Dammam, Eastern, Saudi Arabia