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Completed

NCT Number: NCT04215354

Association Between Fatigue and Balance in Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 2435 Dammam 31451, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic field

Device

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.

Other names: BEMER

Virtual reality

Device

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

Other names: Wii

Primary outcomes

  1. Modified Fatigue Impact Scale

    Time frame: 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.

  2. Balance

    Time frame: 12 weeks.

    Berg Balance Scale (BBS)range from 0(worse condition) to 56(better condition)

  3. balance confidence

    Time frame: 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).

  4. Depression (Beck depression inventory ii (BDI-II))

    Time frame: 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)

  5. Static balance using posturography,

    Time frame: 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 outcomes

  1. Quality of life measurement (Short Form 36 (SF-36)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Collaborators

  • King AbdulAziz City for Science and Technology

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 2, 2020
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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