VASSTII: An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System for Hemiparetic Gait Rehabilitation After Stroke "VASSTII"

Recruiting

Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

1. First ever stroke (ischaemic or haemorrhagic) confirmed on CT or MR imaging
2. Aged 21 - 80 years
3. Stroke duration of > 3 months - 24 months (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 at most minimal aid or supervision.
5. Functional ambulation category (FAC >/= 2) (subject needs at most minimal assistance to walk)

Exclusion Criteria

1. 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
2. Terminal illness such as advanced malignancy, end stage renal failure, neurodegenerative diseases with life expectancy of < 6 months.
3. Aphasia (inability to obey 2 step commands), cognitive impairment, untreated depression or psychiatric disorder.
4. Severe hearing or visual impairment despite aids.
5. 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.
6. Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale >2)
7. Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with warfarin precluding safe fit of unweighting gait harness.
8. Body weight > 130kg.
9. Pregnancy.