An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation "VASST"

Completed

Phase 1 Results

Eligibility Criteria

Inclusion Criteria

1. First ever stroke (ischaemic or haemorrhagic) confirmed on Computed Tomography or Magnetic Resonance imaging
2. Aged 21 - 80 years
3. Stroke duration of >3 months in outpatient phase (subacute -chronic stroke)
4. 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 contact guard or supervision.
5. Functional ambulation category (FAC >/= 2) (Holden et al 1994)

Exclusion Criteria

1. Cardiovascular conditions such as uncontrolled hypertension/hypotension, angina pectoris, recent myocardial infarction, congestive cardiac failure, known echocardiographic ejection fraction < 40% within 3 months of stroke, chronic arrhythmias (e.g. atrial fibrillation) within 3 months of study screening, pacemaker, uncontrolled Diabetes Mellitus.
2. End stage illness (advanced malignancy), pregnancy or end stage renal failure with life expectancy of <6 months.
3. Aphasia (inability to obey 2 step commands), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
4. Active lower limb arthritis, Pain (Visual Analogue Scale) >5/10, fixed orthopaedic deformities of the lower limb which would compromise safe ambulation on treadmill.
5. Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale >2)
6. Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with warfarin precluding safe fit of gait harness