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Association Between Fatigue and Balance in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Magnetic field
Virtual reality
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MULTIPLE SCLEROSIS, FATIGUE, BALANCE

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Imam Abdulrahman Bin Faisal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

MAGNET GROUP

VIRTUAL REALITY

PLACEBO

HEALTHY SUBJECT

Arm Description

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

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.

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 15, 2019
Last Updated
January 2, 2020
Sponsor
Imam Abdulrahman Bin Faisal University
Collaborators
King AbdulAziz City for Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04215354
Brief Title
Association Between Fatigue and Balance in Patients With Multiple Sclerosis
Official Title
Association Between Fatigue and Balance in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
Collaborators
King AbdulAziz City for Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MULTIPLE SCLEROSIS, FATIGUE, BALANCE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
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.
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAGNET GROUP
Arm Type
Experimental
Arm Description
Patients were exposed to very low pulsed electromagnetic field induced by BEMER machine model type: B.BOX Professional using magnet mattress.
Arm Title
VIRTUAL REALITY
Arm Type
Experimental
Arm 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.
Arm Title
PLACEBO
Arm Type
Active Comparator
Arm 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).
Arm Title
HEALTHY SUBJECT
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Magnetic field
Other Intervention Name(s)
BEMER
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Other Intervention Name(s)
Wii
Intervention Description
Wii Fit plus machine which required balance board . It is a video game console designed by Nintendo 2009
Primary Outcome Measure Information:
Title
Modified Fatigue Impact Scale
Description
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.
Time Frame
12 weeks.
Title
Balance
Description
Berg Balance Scale (BBS)range from 0(worse condition) to 56(better condition)
Time Frame
12 weeks.
Title
balance confidence
Description
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).
Time Frame
12 weeks.
Title
Depression (Beck depression inventory ii (BDI-II))
Description
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)
Time Frame
12 weeks.
Title
Static balance using posturography,
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of life measurement (Short Form 36 (SF-36)
Description
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.
Time Frame
12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Imam Abdulrahman Bin Faisal University
City
Dammam
State/Province
Eastern
ZIP/Postal Code
2435 Dammam 31451
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Association Between Fatigue and Balance in Patients With Multiple Sclerosis

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