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Trial registered on ANZCTR


Registration number
ACTRN12611000915954
Ethics application status
Not yet submitted
Date submitted
23/08/2011
Date registered
26/08/2011
Date last updated
26/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving gait initiation after stroke
Scientific title
Does Non Invasive Brain Stimulation Modulate Postural Adjustments after Stroke?
Secondary ID [1] 262900 0
NIL
Universal Trial Number (UTN)
U1111-1123-8992
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 270630 0
Condition category
Condition code
Physical Medicine / Rehabilitation 270797 270797 0 0
Other physical medicine / rehabilitation
Stroke 270808 270808 0 0
Ischaemic
Stroke 270809 270809 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intervention arms in a cross-over design: once only sessions where either active or sham anodal transcranial direct current stimulation is delivered to the lesioned lower limb motor cortex from a Phoresor II stimulator (Model PM850; IOMED) set to deliver 0.5 mA for 10 minutes using an 8 sq cm saline soaked sponge electrode. Intervention arms will be separated by at least 1 week.
Intervention code [1] 269251 0
Rehabilitation
Intervention code [2] 269260 0
Treatment: Devices
Comparator / control treatment
For sham brain stimulation the same protocol will be used and the current ramped back down to zero within 30 seconds of stimulation starting.
The inclusion of a group of healthy subjects is not an intervention control but has been included to allow the comparison of intervention-induced changes of gait initiation measures between stroke with healthy subjects.
Control group
Placebo

Outcomes
Primary outcome [1] 279496 0
Prior to and after brain stimulation, EMG recordings from ankle and knee flexors and extensors of both limbs will be used to estimate the time from an auditory cue to the onset of muscle activation (latency) as subjects initiate stepping.
Timepoint [1] 279496 0
Immediately after brain stimulation
Primary outcome [2] 279503 0
Prior to and after brain stimulation, EMG recordings from ankle and knee flexors and extensors of both limbs will be used to estimate the amplitude of the EMG burst from onset to when the heel leaves the floor as subjects initiate stepping.
Timepoint [2] 279503 0
Immediately after brain stimulation
Primary outcome [3] 279504 0
Prior to and after brain stimulation, subjects will initiate stepping from a pair of three dimensional force plates and the latency from auditory cue to when ground reaction forces begin to change from quiet standing will be recorded. The pattern and variability of centers of pressure in both limbs will also be assessed.
Timepoint [3] 279504 0
Immediately after brain stimulation
Secondary outcome [1] 287749 0
Relationship of effects of brain stimulation and integrity of the corticospinal pathway projecting from the lesioned hemisphere will be assessed by regressing the asymmetry of fractional anisotropy calculated for the posterior limbs of the internal capsules and the latency of EMG onset during gait initiation.
Timepoint [1] 287749 0
MRI scans will be obtained prior to the gait initiation data collection; and the latency of EMG onset during gait initiation will be calculated prior to transcranial direct current stimulation being administered.

Eligibility
Key inclusion criteria
First ever ischemic or haemorrhagic stroke between 6 months and 5 years prior to enrolment; the ability to initiate gait without assistive devices such as walking sticks, handrails; a Fugl-Meyer Lower Limb score between 15 and 30 (out of 34); paretic ankle dorsiflexion of > 10 degrees; the ability to follow instructions; and the ability to give informed consent.
Except for age (>45 years), there are no specific inclusion criteria for healthy subjects.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Brainstem or cerebellar infarction; other neurological or medical disorders that would prevent participation in the study; contraindications to TMS or MRI; and medications that are known to alter motor system excitability.
Healthy subjects will be excluded if they have any neurological disorders; orthopaedic conditions that might affect gait; contraindications to TMS; and medications that are known to alter motor system excitability.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Brain stimulation type will be randomised using opaque envelopes within which a ticket labelled either "sham" or "active-anodal" or "active-cathodal" will be sealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sealed envelopes will be shuffled and the subject will choose an envelope from the stack.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Stroke patients will be assigned to one group and will receive active-anodal or sham stimulation in two sessions, while healthy age-similar subjects will be assigned to another group and receive active-andoal, active-cathodal or sham stimulation in three sessions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3806 0
New Zealand
State/province [1] 3806 0
Auckland

Funding & Sponsors
Funding source category [1] 269724 0
Government body
Name [1] 269724 0
Graduate student training grant from the US National Institutes of Health
Country [1] 269724 0
United States of America
Primary sponsor type
Individual
Name
Dr James Stinear
Address
University of Auckland
Tamaki Campus
261 Morrin Rd
Glen Innes
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 268764 0
University
Name [1] 268764 0
University of Auckland, Dept. Sport & Exercise Science
Address [1] 268764 0
University of Auckland
Tamaki Campus
261 Morrin Rd
Glen Innes
Auckland 1072
Country [1] 268764 0
New Zealand
Other collaborator category [1] 252222 0
Individual
Name [1] 252222 0
Dr Eric Perreault
Address [1] 252222 0
Rehabilitation Institute of Chicago
345 E. Superior St
Chicago IL 60611
Country [1] 252222 0
United States of America

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271687 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 271687 0
Private Bag 92-522
Wellesley St
Auckland 1142
Ethics committee country [1] 271687 0
New Zealand
Date submitted for ethics approval [1] 271687 0
30/08/2011
Approval date [1] 271687 0
Ethics approval number [1] 271687 0

Summary
Brief summary
Stroke affects approximately 56,000 New Zealanders at any point in time. The majority of patients regain their ability to walk but have difficulty initiating stable gait. This instability increases the likelihood of falls, and diminishes the patient’s confidence to walk in the community. Research suggests this instability is caused by poor balance and weakness in the affected leg, plus abnormal commands descending from the brain to the spinal cord that alter the timing of muscle activations in the legs just prior to stepping off. This latter abnormality is the subject of the proposed research. The experiments will determine if safe, painless and weak electrical stimulation administered to the brain through the scalp can restore the generation of normal brain commands and increase stability of gait initiation in stroke survivors. Age-similar healthy control subjects will be included in the study to aid our understanding of the effects of the brain stimulation, and of the mechanisms driving improved stability. Research outcomes are expected to inform the development of new walking-related therapies. The study will also seek to identify patient characteristics that would guide the future delivery of an enhanced therapy on an individualised patient basis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33064 0
Address 33064 0
Country 33064 0
Phone 33064 0
Fax 33064 0
Email 33064 0
Contact person for public queries
Name 16311 0
Dr James Stinear
Address 16311 0
University of Auckland
Dept. Sport & Exercise Science
Tamaki Campus
261 Morrin Rd
Glen Innes
Auckland 1072
Country 16311 0
New Zealand
Phone 16311 0
+64 9 373 7599 ext 82378
Fax 16311 0
Email 16311 0
[email protected]
Contact person for scientific queries
Name 7239 0
Dr James Stinear
Address 7239 0
University of Auckland
Dept. Sport & Exercise Science
Tamaki Campus
261 Morrin Rd
Glen Innes
Auckland 1072
Country 7239 0
New Zealand
Phone 7239 0
+64 9 373 7599 ext 82378
Fax 7239 0
Email 7239 0
[email protected]

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