An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation (VASST)
This study has been completed.
Information provided by (Responsible Party):
Chua Sui Geok, Karen, Tan Tock Seng Hospital
First received: March 5, 2013
Last updated: January 2, 2015
Last verified: January 2015
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.
Device: Variable Speed and Sensing Treadmill
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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."
Primary Outcome Measures:
- 6 Minute Walk Test (Metres) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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)
- 10 Meter Walk Test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
Experimental: supervised treadmill training
Supervised treadmill training on variable sensing treadmill.
Device: Variable Speed and Sensing Treadmill
open label study on variable speed and sending treadmill training for hemiplegic gait training.
Other Name: VASST
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01811680
|TTSH Rehab Medicine, Centre of Advanced Rehablitation Therapeutics (CART) , 11 Jalan Tan Tock Seng Hospital
|Singapore, Singapore, 308433 |
Tan Tock Seng Hospital
||Chua Karen, MD
||Tan Tock Seng Hospital
||Chua Sui Geok, Karen, Principal Investigator, Tan Tock Seng Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 5, 2013
|Results First Received:
||September 12, 2014
||January 2, 2015
||Singapore: Domain Specific Review Boards
Keywords provided by Tan Tock Seng Hospital:
ClinicalTrials.gov processed this record on May 26, 2016
Variable automated treadmill treadmill