VASSTII: An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System for Hemiparetic Gait Rehabilitation After Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Tan Tock Seng Hospital
Sponsor:
Collaborator:
Ngee Ann Polytechnic
Information provided by (Responsible Party):
Chua Sui Geok, Karen, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT01996137
First received: November 21, 2013
Last updated: July 3, 2014
Last verified: July 2014
  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
Stroke
Hemiplegic Gait
Device: VASST

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System for Hemiparetic Gait Rehabilitation After Stroke

Resource links provided by NLM:


Further study details as provided by Tan Tock Seng Hospital:

Primary Outcome Measures:
  • 6 minute walk test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    distance (metres) walked in 6 minutes


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

  • Functional ambulation categoryFAC [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The level of independence or aid needed for walking


Estimated Enrollment: 11
Study Start Date: April 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VASST
Stroke patients selected to undergo treadmill
Device: VASST
Stroke patients with hemiparesis undergo gait training via VASST

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 21, 2013
Last Updated: July 3, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Tan Tock Seng Hospital:
Stroke
Treadmill
Gait Speed

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014