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Clinical Trials/NCT04215354
NCT04215354
Completed
Not Applicable

Association Between Fatigue and Balance in Patients With Multiple Sclerosis

Imam Abdulrahman Bin Faisal University1 site in 1 country95 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Imam Abdulrahman Bin Faisal University
Enrollment
95
Locations
1
Primary Endpoint
Depression (Beck depression inventory ii (BDI-II))
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
May 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abeer Saeed Alawami

Master student

Imam Abdulrahman Bin Faisal University

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.

Outcomes

Primary Outcomes

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)

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).

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)

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

  • Quality of life measurement (Short Form 36 (SF-36)(12 weeks.)

Study Sites (1)

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