Association Between Fatigue and Balance in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Depression (Beck depression inventory ii (BDI-II))
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Depression (Beck depression inventory ii (BDI-II))
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 12 weeks.
Berg Balance Scale (BBS)range from 0(worse condition) to 56(better condition)
Static balance using posturography,
时间窗: 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.
次要结局
- Quality of life measurement (Short Form 36 (SF-36)(12 weeks.)
研究者
Abeer Saeed Alawami
Master student
Imam Abdulrahman Bin Faisal University