Stroke Clinical Trial
— VASSTIIOfficial title:
An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill (VASST II) System for Hemiparetic Gait Rehabilitation After Stroke
Verified date | September 2019 |
Source | Tan Tock Seng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%.
Status | Completed |
Enrollment | 11 |
Est. completion date | June 15, 2019 |
Est. primary completion date | June 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Tan Tock Seng Hospital CART 5B | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital | Ngee Ann Polytechnic Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6 minute walk test | distance (metres) walked in 6 minutes | 6 weeks | |
Secondary | Gait speed | seconds taken to walk 10 metre | 6 weeks | |
Secondary | Functional ambulation category FAC | Walking independence description | 6 weeks |
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