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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chua Sui Geok, Karen, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT01811680
First received: March 5, 2013
Last updated: July 30, 2013
Last verified: July 2013

March 5, 2013
July 30, 2013
August 2012
July 2013   (final data collection date for primary outcome measure)
1. 6 minute walk test (metres/second) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
gait speed ( metres/s) on self selected walking speed using 6 minute walk test
Same as current
Complete list of historical versions of study NCT01811680 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation
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."

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stroke
  • Hemiplegic Gait
Device: Variable Speed and Sensing Treadmill
open label study on variable speed and sending treadmill training for hemiplegic gait training.
Other Name: VASST
Experimental: supervised treadmill training
Supervised treadmill training on variable sensing treadmill.
Intervention: Device: Variable Speed and Sensing Treadmill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01811680
NHG DSRB_D_2012/00571
No
Chua Sui Geok, Karen, Tan Tock Seng Hospital
Tan Tock Seng Hospital
Not Provided
Principal Investigator: Chua Karen, MD Tan Tock Seng Hospital
Tan Tock Seng Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP