Multiple SclerosisNCT04215354
Association Between Fatigue and Balance in Patients With Multiple Sclerosis
A study testing Magnetic field and Virtual reality in people with Multiple Sclerosis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Magnetic field and Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- Cardiac arrhythmia.
- Large aneurysm.
- Heavy psychosis.
- Otitis media in last 2 weeks.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Imam Abdulrahman Bin Faisal University
Dammam, Eastern Province, 2435 Dammam 31451
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Magnetic field, Virtual reality
- Keywords
- MULTIPLE SCLEROSIS, FATIGUE, BALANCE
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic fieldDevice
Also called BEMER
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 realityDevice
Also called Wii
Wii Fit plus machine which required balance board . It is a video game console designed by Nintendo 2009
| Study group | Role | What they receive |
|---|---|---|
| MAGNET GROUP | Experimental | Patients were exposed to very low pulsed electromagnetic field induced by BEMER machine model type: B.BOX Professional using magnet mattress. Receives: 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. Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks.
Balance
Berg Balance Scale (BBS)range from 0(worse condition) to 56(better condition)
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study startSep 2014
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Responsible party
- Principal investigator, Abeer Saeed Alawami, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215354
- Sponsor's protocol ID
- IRB-2014-04-319
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Fatigue and Balance in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04215354
- Acronym / sponsor ID
- IRB-2014-04-319
- Conditions
- Multiple Sclerosis
- Keywords
- MULTIPLE SCLEROSIS, FATIGUE, BALANCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Study start
- Sep 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MAGNET GROUP | Experimental | Device: Magnetic fieldPatients were exposed to very low pulsed electromagnetic field induced by BEMER machine model type: B.BOX Professional using magnet mattress. |
| VIRTUAL REALITY | Experimental | Device: Virtual realityBalance 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. |
| PLACEBO | Active comparator | Device: Magnetic fieldPatients 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 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- An acute episode of MS within the last 30 days.
- Pregnancy at any stage.
- Severely blurred vision.
- A pacemaker.
- Epilepsy of any type.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic fieldAlso: BEMERLow 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. | Device | MAGNET GROUP, PLACEBO |
| Virtual realityAlso: WiiWii Fit plus machine which required balance board . It is a video game console designed by Nintendo 2009 | Device | VIRTUAL REALITY |
Primary outcome
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.
Balance
Time frame: 12 weeks.
Berg Balance Scale (BBS)range from 0(worse condition) to 56(better condition)
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).
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)
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.
1 secondary outcome
Quality of life measurement (Short Form 36 (SF-36)
Time frame: 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic field and Virtual reality in people with Multiple Sclerosis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fatigue Impact Scale (time frame: 12 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.