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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01811680
First Posted: March 14, 2013
Last Update Posted: January 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chua Sui Geok, Karen, Tan Tock Seng Hospital
  Purpose

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.


Condition Intervention Phase
Stroke Hemiplegic Gait Device: Variable Speed and Sensing Treadmill Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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."

Resource links provided by NLM:


Further study details as provided by Chua Sui Geok, Karen, Tan Tock Seng Hospital:

Primary Outcome Measures:
  • 6 Minute Walk Test (Metres) [ Time Frame: 8 weeks ]
    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 ]
    Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)


Enrollment: 10
Study Start Date: August 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811680


Locations
Singapore
TTSH Rehab Medicine, Centre of Advanced Rehablitation Therapeutics (CART) , 11 Jalan Tan Tock Seng Hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital
Investigators
Principal Investigator: Chua Karen, MD Tan Tock Seng Hospital
  More Information

Responsible Party: Chua Sui Geok, Karen, Principal Investigator, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT01811680     History of Changes
Other Study ID Numbers: NHG DSRB_D_2012/00571
First Submitted: March 5, 2013
First Posted: March 14, 2013
Results First Submitted: September 12, 2014
Results First Posted: December 4, 2014
Last Update Posted: January 5, 2015
Last Verified: January 2015

Keywords provided by Chua Sui Geok, Karen, Tan Tock Seng Hospital:
Stroke
Hemiplegia
Variable automated treadmill treadmill

Additional relevant MeSH terms:
Stroke
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors