Sensor-Based Analysis And rehabiLitation of bAlance in Neurological Diseases: a multiCentric randomizEd Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
Balance impairment is one of the most common disorders due to a neurological diseases. Sensor-based technologies may be useful for falls prevention and balance recovery during patients hospitalization. OAK Elderly Care System (Khymeia Group, Noventa Padovana, Italy) allows the assessment of fall risk, the centre of pressure and the execution of balance exercises in a virtual environment.
详细描述
The aim of the study is to compare the therapy provided by means of the OAK Elderly Care System with conventional physiotherapy for balance rehabilitation in patients affected by stroke, Multiple Sclerosis (MS) and Parkinson Disease (PD).
OAK Elderly Care System consists of two independent balance boards and three sensors for the kinematic tracking of the trunk and lower limbs. These components allow the assessment of the centre of pressure and the execution of exercises in a virtual environment.
120 patients (40 stroke, 40 MS, 40 PK) hospitalized at 4 different italian hospitals, were enrolled according to inclusion and exclusion criteria and randomly assigned to two groups (i.e. intervention group, control group). Intervention group received 1 daily hour of technology-based treatment, while the control group underwent 1 daily hour of physiotherapy for balance rehabilitation, in addiction to 1 hour of conventional physiotherapy. Both treatments lasted 15 sessions. Before and after treatment balance, walking, daily living autonomy and pathology-specific features were assessed.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common criteria:
- •Berg Balance Scale < 50/56;
- •Ability to maintain the standing position with o without one support for 1 minute;
- •Functional Independence measure < 100/126;
- •Barthel Index < 80/
- •Single ischemic stroke;
- •Lesion occured after 2 and within 18 months;
- •National Institute of Health Stroke Scale ≤
- •1.5 < Hoehn & Yahr < 3;
- •Subitem "freezing when walking"of the UPDRS ≤
- •Multiple Sclerosis:
- •Relapsing remitting or secondary progressive Multiple Sclerosis;
- •Expanded Disability Status Scale ≤ 6.5.
排除标准
- •Untreated epilepsy;
- •Major depressive disorder;
- •Fractures;
- •Dementia;
- •Ideomotor Apraxia;
- •Severe impairment of verbal comprehension;
- •Severe acoustic and visual disorders.
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 56).
次要结局
- Number of falls during the last year(Change from baseline number of falls during the last year scale at the end of the therapy (three weeks thereafter))
- Activities specific-Balance Confidence scale (ABC)(Change from baseline Activities specific-Balance Confidence scale at the end of the therapy (three weeks thereafter))
- Barthel Index (BI)(Change from baseline Barthel Index at the end of the therapy (three weeks thereafter))
- National Institution of Health Stroke Scale (NIHSS)(Change from baseline National Institute of Health Stroke Scale at the end of the therapy (three weeks thereafter))
- Hoehn & Yahr Scale (H&Y)(Change from baseline Hoehn & Yahr Scale at the end of the therapy (three weeks thereafter))
- Kurtzke Extended Disability Status Scale (EDSS)(Change from baseline Kurtzke Extended Disability Status Scale at the end of the therapy (three weeks thereafter))
- Functional Independence Measure (FIM)(Change from baseline Functional Independence Measure at the end of the therapy (three weeks thereafter))
- Unified Parkinson's Disease Rating Scale (UPDRS)(Change from baseline Unified Parkinson's Disease Rating Scale at the end of the therapy (three weeks thereafter))
- Functional Ambulation Classification (FAC)(Change from baseline Functional Ambulation Classification at the end of the therapy (three weeks thereafter))