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VASSTII: An Exploratory Clinical Study on a VASST IITreadmill System for Post Stroke Gait Rehabilitation. (VASSTII)

This study is currently recruiting participants.
Verified February 2017 by Chua Sui Geok, Karen, Tan Tock Seng Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996137
First Posted: November 27, 2013
Last Update Posted: February 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ngee Ann Polytechnic
Information provided by (Responsible Party):
Chua Sui Geok, Karen, Tan Tock Seng Hospital
  Purpose

An exploratory clinical study on a Variable Speed and Sensing Treadmill system(VASST) for hemiparetic gait rehabilitation after stroke.

Building upon the positive results of VASST I conducted in 2012, VASST II will be an open label pilot trial of 11 subjects screened for eligibility by TTSH medical and rehabilitation team Study hypotheses : Training on VASST may result in a gain of +40% - 50% for distance walked and +10-20% of gait speed compared to baseline and response rate of 85% and serious adverse event rate of <10%.


Condition Intervention Phase
Stroke Hemiplegic Gait Device: VASST Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
1 hour of VASST II training
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill (VASST II) System for Hemiparetic Gait Rehabilitation After Stroke

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 [ Time Frame: 6 weeks ]
    distance (metres) walked in 6 minutes


Secondary Outcome Measures:
  • Gait speed [ Time Frame: 6 weeks ]
    metres/second over 10 metre walk test

  • Functional ambulation categoryFAC [ Time Frame: 6 weeks ]
    The level of independence or aid needed for walking


Estimated Enrollment: 11
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VASST II
Stroke patients selected to undergo VASST II treadmill training for 60 minutes
Device: VASST
Stroke patients with hemiparesis undergo gait training via VASST

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. First ever stroke (ischaemic or haemorrhagic) confirmed on CT or MR imaging
  2. Aged 21 - 80 years
  3. Stroke duration of > 3 months - 24 months (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 at most minimal aid or supervision.
  5. Functional ambulation category (FAC >/= 2) (subject needs at most minimal assistance to walk)

Exclusion Criteria:

  1. Cardiovascular conditions such as uncontrolled hypertension/hypotension, angina pectoris, recent myocardial infarction, congestive cardiac failure, known echocardiographic ejection fraction < 40%, chronic arrhythmias (e.g. atrial fibrillation), pacemaker, uncontrolled Diabetes Mellitus.; within 3 months of study screening
  2. Terminal illness such as advanced malignancy, end stage renal failure, neurodegenerative diseases with life expectancy of < 6 months.
  3. Aphasia (inability to obey 2 step commands), cognitive impairment, untreated depression or psychiatric disorder.
  4. Severe hearing or visual impairment despite aids.
  5. Active lower limb arthritis, lower limb or joint pain (Visual Analogue Scale) >5/10, fixed orthopaedic deformities and peripheral vascular disease of the lower limb which could be worsened by treadmill training.
  6. Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale >2)
  7. Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with warfarin precluding safe fit of unweighting gait harness.
  8. Body weight > 130kg.
  9. Pregnancy.
  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): NCT01996137


Contacts
Contact: Karen SG Chua, MBBS,FRCP 65 64506 164 Karen_Chua@ttsh.com.sg
Contact: CJ Wong, MBBS,MRCP 6564506181 wong_chin_jung@ttsh.com.sg

Locations
Singapore
Tan Tock Seng Hospital CART 5B Recruiting
Singapore, Singapore, 308433
Contact: Karen S Chua, MBBS, FRCP    68894580    Karen_Chua@ttsh.com.sg   
Contact: CJ Wong, MBBS,MRCP    64506181    Wong_chin_jung@ttsh.com.sg   
Principal Investigator: Karen SG Chua, MBBS,FRCP         
Sub-Investigator: Chin Jung Wong, MBBS,MRCP         
Sponsors and Collaborators
Tan Tock Seng Hospital
Ngee Ann Polytechnic
Investigators
Principal Investigator: Karen SG Chua, MBBS,FRCP Tan Tock Seng Hospital
  More Information

Responsible Party: Chua Sui Geok, Karen, Doctor, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT01996137     History of Changes
Other Study ID Numbers: NHGDSRB_D_2013/01042
First Submitted: November 21, 2013
First Posted: November 27, 2013
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chua Sui Geok, Karen, Tan Tock Seng Hospital:
Stroke
Treadmill
Gait Speed

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