NCT04215354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 6, 2020

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

December 15, 2019

Last Update Submit

January 2, 2020

Conditions

Multiple Sclerosis

Keywords

MULTIPLE SCLEROSISFATIGUEBALANCE

Outcome Measures

Primary Outcomes (5)

  • 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.

  • Balance

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

    12 weeks.

  • 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.

  • 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.

  • 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 Outcomes (1)

  • Quality of life measurement (Short Form 36 (SF-36)

    12 weeks.

Study Arms (4)

MAGNET GROUP

EXPERIMENTAL

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

Device: Magnetic field

VIRTUAL REALITY

EXPERIMENTAL

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.

Device: Virtual reality

PLACEBO

ACTIVE COMPARATOR

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).

Device: Magnetic field

HEALTHY SUBJECT

NO INTERVENTION

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.

Interventions

Magnetic fieldDEVICE

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.

Also known as: BEMER
MAGNET GROUPPLACEBO
Virtual realityDEVICE

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

Also known as: Wii
VIRTUAL REALITY

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 2435 Dammam 31451, Saudi Arabia

Location

MeSH Terms

Conditions

Multiple SclerosisFatigue

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

December 15, 2019

First Posted

January 2, 2020

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

January 6, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)