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

January 2, 2015 updated by: Chua Sui Geok, Karen, Tan Tock Seng Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • TTSH Rehab Medicine, Centre of Advanced Rehablitation Therapeutics (CART) , 11 Jalan Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • VASST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks
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)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Investigators

  • Principal Investigator: Chua Karen, MD, Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Estimate)

January 5, 2015

Last Update Submitted That Met QC Criteria

January 2, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHG DSRB_D_2012/00571

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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