An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill (VASST II) System for Hemiparetic Gait Rehabilitation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- 6 minute walk test
研究概览
简要总结
An exploratory clinical study on a Variable Speed and Sensing Treadmill system(VASST) for hemiparetic gait rehabilitation after stroke.
Building upon the positive results of VASST I conducted in 2012, VASST II will be an open label pilot trial of 11 subjects screened for eligibility by TTSH medical and rehabilitation team Study hypotheses : Training on VASST may result in a gain of +40% - 50% for distance walked and +10-20% of gait speed compared to baseline and response rate of 85% and serious adverse event rate of <10%.
详细描述
A recent collaboration with Ngee Ann Polytechnic's team from the Biomedical Engineering Centre, Electronic & Computer Engineering Division, School Of Engineering Singapore yielded the VASST I; an innovative product, the result of co development between NP and TTSH rehabilitation centre's CART (Centre for Advanced Rehabilitation Therapeutics) was supported by a competitive grant. (EMBC paper ref, SIRF)
VASST I incorporates the following features which enhance manual treadmill training:
- Sensing mechanisms to track user's self-activated actions during exercise.
- Automated speed-control to adapt to a user's gait speed and pattern.
- Safety sensing to slow down the treadmill when the user is unable to sustain the treadmill speed in order to avert a potential fall.
- Overhead safety harness without body weight support for reduction of fall risk.
- Software tools to collect vital clinical data regarding ambulatory gait speed, distance and time walked during treatment.
A recently completed proof of concept trial in June 2013 yielded encouraging results in 10 chronic poststroke hemiplegic subjects. All subjects completed the trial without any adverse events. The clinical team was able to smoothly test-bed VASST in 10 subjects with good subjective feedback. Following 12 hour - long supervised training sessions over 4 weeks, there were significant gains from baseline for measures of gait quantity (+30.1%) and gait speed (+8.7%). These gains were maintained for up to 4 weeks after training ceased. The response rate was 80% and positive feedback was obtained in 80% of subjects. Objective measurements were obtained using independent kinematic gait analysis using the Gaitrite system.
With these encouraging results, the combined TTSH and Ngee Ann medical and bioengineering teams have brought the co-development to a deeper level, leading to VASST II which is conceptualized as a pre-commercialisation prototype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ever stroke (ischaemic or haemorrhagic) confirmed on CT or MR imaging
- •Aged 21 - 80 years
- •Stroke duration of > 3 months - 24 months (subacute -chronic stroke)
- •Able to walk overground at a self-selected speed of >0.2m/s with or without walking aids or lower limb orthoses for at least 150 meters with at most minimal aid or supervision.
- •Functional ambulation category (FAC >/= 2) (subject needs at most minimal assistance to walk)
排除标准
- •Cardiovascular conditions such as uncontrolled hypertension/hypotension, angina pectoris, recent myocardial infarction, congestive cardiac failure, known echocardiographic ejection fraction < 40%, chronic arrhythmias (e.g. atrial fibrillation), pacemaker, uncontrolled Diabetes Mellitus.; within 3 months of study screening
- •Terminal illness such as advanced malignancy, end stage renal failure, neurodegenerative diseases with life expectancy of < 6 months.
- •Aphasia (inability to obey 2 step commands), cognitive impairment, untreated depression or psychiatric disorder.
- •Severe hearing or visual impairment despite aids.
- •Active lower limb arthritis, lower limb or joint pain (Visual Analogue Scale) >5/10, fixed orthopaedic deformities and peripheral vascular disease of the lower limb which could be worsened by treadmill training.
- •Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale >2)
- •Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with warfarin precluding safe fit of unweighting gait harness.
- •Body weight > 130kg.
研究组 & 干预措施
VASST II
Stroke patients selected to undergo VASST II treadmill training for 60 minutes x15 sessions over 5 weeks Outcomes at week 0.3 6.12.24
干预措施: VASST II treadmill (Device)
结局指标
主要结局
6 minute walk test
时间窗: 6 weeks
distance (metres) walked in 6 minutes
次要结局
- Gait speed(6 weeks)
- Functional ambulation category FAC(6 weeks)
研究者
Chua Sui Geok, Karen
Doctor
Tan Tock Seng Hospital