Skip to content

Association Between Fatigue and Balance in Patients With Multiple Sclerosis

Association Between Fatigue and Balance in Patients With Multiple Sclerosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04215354
Enrollment
95
Registered
2020-01-02
Start date
2014-09-30
Completion date
2016-05-31
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

MULTIPLE SCLEROSIS, FATIGUE, BALANCE

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.

Interventions

DEVICEMagnetic 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.

DEVICEVirtual reality

Wii Fit plus machine which required balance board . It is a video game console designed by Nintendo 2009

Sponsors

King AbdulAziz City for Science and Technology
CollaboratorOTHER
Imam Abdulrahman Bin Faisal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Potential participants were informed that they will be randomly allocated in one of the three study groups: the magnet (BEMER) group, virtual reality (Wii) group or the placebo group.

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Modified Fatigue Impact Scale12 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.
Balance12 weeks.Berg Balance Scale (BBS)range from 0(worse condition) to 56(better condition)
balance confidence12 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).
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)
Static balance using posturography,12 weeksstability 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

MeasureTime frameDescription
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.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026