Possibilities of Using Telerehabilitation for the Therapy of Balance and Walking Disorders in Patients With Multiple Sclerosis in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in balance (One leg stance)
研究概览
简要总结
The study will compare the effect of individual telerehabilitation with offline remote exercise through videos and with a control group without intervention. The monitored group will be people with multiple sclerosis with balance impairment. The duration of the intervention will be 12 weeks.
详细描述
Total of 60 persons will be randomly divided into two experimental and one control groups. After dividing into individual groups, all probands will be examined using objective and subjective tests for balance and walking. The same testing will be done after the end of the 12-week intervention.
The group with individual telerehabilitation will exercise twice a week. The exercise will consist of strength and balance exercises using the Homebalance ® system. For direct synchronous contact between the physiotherapist and the patient, an audiovisual link via the freely available ZOOM app was used.
The second experimental group will receive 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise twice a week.
The control group receives no intervention.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of definite MS
- •subjectively perceived balance impairment
- •clinically stable MS (at least 30 days since the last attack of the disease)
- •ability to independently operate a PC or tablet, and
排除标准
- •severe cognitive deficits that would interfere with understanding exercise instructions
- •presence of other disease adversely affecting balance impairment
结局指标
主要结局
Change in balance (One leg stance)
时间窗: Baseline to week 12
One leg stance is test that evaluates balance. In the test, the time for which the tested person can stand on one leg is measured.
Change in functional mobility (Timed Up and Go)
时间窗: Baseline to week 12
Timed Up and Go test (TUG) is test used to measure functional mobility. The TUG test measures how long it takes to stand up, walk a distance of 3 metres, turn, walk back, and sit down again.
Change in balance (Berg Balance Scale)
时间窗: Baseline to week 12
Berg Balance Scale (BBS) is 14-item scale that evaluates balance.The 14 items are rated on either a 5-point (0-4) scale.
Change in functional mobility (Timed Up and Go Cognitive)
时间窗: Baseline to week 12
Timed Up and Go Cognitive (TUG Cognitive) is test used to measure functional mobility. The TUG test measures how long it takes to stand up, walk a distance of 3 metres, turn, walk back, and sit down again with an added cognitive task.
次要结局
- Change in walk (Multiple Sclerosis Walking Scale 12)(Baseline to week 12)
- Change in balance (Activity Balance Scale)(Baseline to week 12)
- Change in balance (Falls Efficacy Scale-I)(Baseline to week 12)
- Change in fatigue (Modified Fatigue Impact Scale)(Baseline to week 12)
研究者
Barbora Staníčková
Possibilities of using telerehabilitation for the therapy of balance and walking disorders in patients with multiple sclerosis in clinical practice
Charles University, Czech Republic