Clinical trial NCT01811680: An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation
Official 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."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Hemiplegic Gait
Keywords: Stroke
Hemiplegia
Variable automated treadmill treadmill
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 Minute Walk Test (Metres)
timeFrame: 8 weeks
measure: 10 Meter Walk Test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: TTSH Rehab Medicine, Centre of Advanced Rehablitation Therapeutics (CART) , 11 Jalan Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Chua Karen, MD
role: PRINCIPAL_INVESTIGATOR
References: