Stroke Clinical Trial
— VASSTOfficial title:
A Phase 1 Study of "An Exploratory Feasibility Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation in Subacute Stroke Patients."
Verified date | January 2015 |
Source | Tan Tock Seng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Domain Specific Review Boards |
Study type | Interventional |
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 phase 1 feasibility and safety trial on the above device for 10
chronic stroke patients with hemiparetic gait dysfunction to be conducted over a period of 2
months.
Research protocol and standardized outcomes measures will be used.
Status | Completed |
Enrollment | 10 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | TTSH Rehab Medicine, Centre of Advanced Rehablitation Therapeutics (CART) , 11 Jalan Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6 Minute Walk Test (Metres) | 6 minute walk test - assess distance walked within 6 minutes as a sub maximal test of endurance (Assessed at weeks 0,2,4 and 8) | 8 weeks | No |
Primary | 10 Meter Walk Test | Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8) | 8 weeks | No |
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