NCT01811680

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 4, 2014

Completed
Last Updated

January 5, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

March 5, 2013

Results QC Date

September 12, 2014

Last Update Submit

January 2, 2015

Conditions

StrokeHemiplegic Gait

Keywords

StrokeHemiplegiaVariable automated treadmill treadmill

Outcome Measures

Primary Outcomes (2)

  • 6 Minute Walk Test (Metres)

    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

    Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)

    8 weeks

Study Arms (1)

supervised treadmill training

EXPERIMENTAL

Supervised treadmill training on variable sensing treadmill.

Device: Variable Speed and Sensing Treadmill

Interventions

Variable Speed and Sensing TreadmillDEVICE

open label study on variable speed and sending treadmill training for hemiplegic gait training.

Also known as: VASST
supervised treadmill training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First ever stroke (ischaemic or haemorrhagic) confirmed on Computed Tomography or Magnetic Resonance imaging
  • Aged 21 - 80 years
  • Stroke duration of \>3 months in outpatient phase (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 contact guard or supervision.
  • Functional ambulation category (FAC \>/= 2) (Holden et al 1994)

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% within 3 months of stroke, chronic arrhythmias (e.g. atrial fibrillation) within 3 months of study screening, pacemaker, uncontrolled Diabetes Mellitus.
  • End stage illness (advanced malignancy), pregnancy or end stage renal failure with life expectancy of \<6 months.
  • Aphasia (inability to obey 2 step commands), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
  • Active lower limb arthritis, Pain (Visual Analogue Scale) \>5/10, fixed orthopaedic deformities of the lower limb which would compromise safe ambulation on treadmill.
  • 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 gait harness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

StrokeGait Disorders, NeurologicHemiplegia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

There were technical limitations due to Gaitrite walkway malfunction midway in the trial leading to unreliable cadence results. Step length results were not affected.

Results Point of Contact

Title
Dr Karen Chua
Organization
Tan Tock Seng Hospital
karen_chua@ttsh.com.sg
65 68894580

Study Officials

  • Chua Karen, MD

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 14, 2013

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 5, 2015

Results First Posted

December 4, 2014

Record last verified: 2015-01

Locations

SG(1)