NCT01996137

Brief Summary

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
4.8 years until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

November 21, 2013

Last Update Submit

September 11, 2019

Conditions

StrokeHemiplegic Gait

Keywords

StrokeTreadmillGait Speed

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk test

    distance (metres) walked in 6 minutes

    6 weeks

Secondary Outcomes (2)

  • Gait speed

    6 weeks

  • Functional ambulation category FAC

    6 weeks

Study Arms (1)

VASST II

EXPERIMENTAL

Stroke patients selected to undergo VASST II treadmill training for 60 minutes x15 sessions over 5 weeks Outcomes at week 0.3 6.12.24

Device: VASST II treadmill

Interventions

VASST II treadmillDEVICE

Supervised treadmill training under physiotherapist

Also known as: Variable Automated Speed and Sensing Treadmill version II
VASST II

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • Terminal illness such as advanced malignancy, end stage renal failure, neurodegenerative diseases with life expectancy of \< 6 months.
  • Aphasia (inability to obey 2 step commands), cognitive impairment, untreated depression or psychiatric disorder.
  • Severe hearing or visual impairment despite aids.
  • 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.
  • Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale \>2)
  • Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with warfarin precluding safe fit of unweighting gait harness.
  • Body weight \> 130kg.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital CART 5B

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karen SG Chua, MBBS,FRCP

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 1 hour of VASST II training, total 15 sessions over 5 weeks continuously
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

September 24, 2018

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)