Status:
COMPLETED
An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation
Lead Sponsor:
Tan Tock Seng Hospital
Conditions:
Stroke
Hemiplegic Gait
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
To conduct a feasibility clinical trial to test a novel patient sensing automated treadmill device devised by local engineers for subacute hemiplegic stroke patients for gait rehabilitation. This is a...
Detailed Description
To conduct a feasibility clinical trial to test a novel patient sensing automated treadmill device devised by local engineers for subacute hemiplegic stroke patients for gait rehabilitation. This devi...
Eligibility Criteria
Inclusion
- First ever stroke (ischaemic or haemorrhagic) confirmed on Computed Tomography or Magnetic Resonance imaging
- Aged 21 - 80 years
- Stroke duration of \>3 months in outpatient phase (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 contact guard or supervision.
- Functional ambulation category (FAC \>/= 2) (Holden et al 1994)
Exclusion
- 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.
- End stage illness (advanced malignancy), pregnancy or end stage renal failure with life expectancy of \<6 months.
- Aphasia (inability to obey 2 step commands), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
- Active lower limb arthritis, Pain (Visual Analogue Scale) \>5/10, fixed orthopaedic deformities of the lower limb which would compromise safe ambulation on treadmill.
- 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 gait harness
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01811680
Start Date
August 1 2012
End Date
July 1 2013
Last Update
January 5 2015
Active Locations (1)
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1
TTSH Rehab Medicine, Centre of Advanced Rehablitation Therapeutics (CART) , 11 Jalan Tan Tock Seng Hospital
Singapore, Singapore, 308433