Impact of the Use of a Weighted Jacket on the Balance (While Walking or Standing) of Patients With a Balance Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Imbalance
研究概览
简要总结
The aim of the study is to test whether wearing a weighted jacket can help improve the balance distortion of patients with neurologic pathologies.
The center of mass of the patient will be analyzed in order to determine the direction in which the imbalance is most important. Weights will be placed accordingly in a jacket in order to correct the imbalance. In the experimental group, weights will represent 1.5 to 2% of the patient body mass. In the control group, the investigators will use weights of 200 grams maximum, placed evenly on both sides of the jacket. Patients will wear the jacket for 2 consecutive hours.
After wearing the jacket for 2 hours, data similar to those recorded at the beginning of the experiment will be taken again, namely the determination of the center of mass and of the deviations caused by the imbalance.
A final series of tests will take place approximately one week after wearing the jacket, to determine if there are any residual effects.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good level of French understanding
- •be able to walk a minimum distance of 10 meters with or without rod/walker
- •walk 10 meters in more than 12 seconds.
- •have a diagnosis of Multiple Sclerosis, Parkinson's, or any other neurological pathology that could cause balance disorders
- •be able to endure at least 2 hours of tests, interviews or medical care.
- •score of more than 8 seconds at the time up and go (TUG), less than 24 points out of 28 in the Tinetti test
排除标准
- •the patient underwent a period of exacerbation of his pathology in the last two months (especially for multiple sclerosis patients)
- •chronic back pain
- •poor eyesight (not be able to perform the tests)
- •osteoporosis
研究组 & 干预措施
Imbalance correction
干预措施: Personalized weighted jacket (Device)
Control
干预措施: Control jacket (Device)
结局指标
主要结局
Imbalance
时间窗: Data measured after 2 hours of jacket utilisation
The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.
Time Up and Go
时间窗: Data measured after 2 hours of jacket utilisation
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Tinetti test
时间窗: Data measured after 2 hours of jacket utilisation
The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
Berg balance scale
时间窗: Data measured after 2 hours of jacket utilisation
The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
次要结局
- Imbalance(1 week after jacket utilisation)
- Time Up and Go(1 week after jacket utilisation)
- Tinetti test(1 week after jacket utilisation)
- Berg balance scale(1 week after jacket utilisation)
研究者
Bernard Dachy
Head of neurology department
Brugmann University Hospital