Association Between Fatigue and Balance in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Association Between Fatigue and Balance in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215354
• Other study ID #: IRB-2014-04-319
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: December 2019
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Magnetic field
Low pulsed electromagnetic field induced by BEMER machine model type: B.BOX Professional, model NO: 420200, 12-15 Volt, with maximum 300 Watt and average flux density around 35 microtesla- (BEMER Liechtenstein product, USA). Mattress which is flexible, 6 flat coil was used for whole body therapy.
• Virtual reality
Wii Fit plus machine which required balance board . It is a video game console designed by Nintendo 2009

Locations

Country	Name	City	State
Saudi Arabia	Imam Abdulrahman Bin Faisal University	Dammam	Eastern

Sponsors (2)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University	King AbdulAziz City for Science and Technology

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Fatigue Impact Scale	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.	12 weeks.
Primary	Balance	Berg Balance Scale (BBS)range from 0(worse condition) to 56(better condition)	12 weeks.
Primary	balance confidence	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).	12 weeks.
Primary	Depression (Beck depression inventory ii (BDI-II))	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)	12 weeks.
Primary	Static balance using posturography,	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.	12 weeks
Secondary	Quality of life measurement (Short Form 36 (SF-36)	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.	12 weeks.