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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 device incorporates patient automated variable speeds and feedback, increased safety features with patient support harness and visual feedback providing ambulatory gait monitoring data. Methodology: 10 stable subacute hemiparetic stroke subjects will undergo supervised treadmill training using this device targeted at improving gait speed and walking independence. Outcomes will be measured at 4 time points pre and post training using clinical scales and temporal-spatial gait measurements. Importance of research to medicine: This study tests the possibility of patient initiated control and closed loop sensing feedback system to provide increased intensity, reduced risk of gait destabilisation and fall risk which are associated with current fixed treadmill training. Potential benefits with new device: Ability to train at self selected variable speeds including fast speeds, improved hemiplegic leg swing initiation and stride length, less assistance required from physiotherapist and reduced fall risk due to overhead safety harness and treadmill sensing and increased patient confidence. Possibility of ambulatory gait speed and force loading during treadmill training. Potential risks: Minor risks of fall are minimised as there is a safety harness and supervision by physiotherapist. Anticipated risks related to repetitive treadmill training with regards to cardiovascular and musculoskeletal side effects will be mitigated with strict patient inclusion and exclusion criteria.

Official Title
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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.

Conditions
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Stroke, Hemiplegic Gait

Intervention / Treatment
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* Device: Variable Speed and Sensing Treadmill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supervised treadmill training<br>Supervised treadmill training on variable sensing treadmill. | Device: Variable Speed and Sensing Treadmill<br>* open label study on variable speed and sending treadmill training for hemiplegic gait training.<br>* Other names: VASST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Hemiplegia, Variable automated treadmill treadmill