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Trial registered on ANZCTR


Registration number
ACTRN12618000094279
Ethics application status
Approved
Date submitted
12/01/2018
Date registered
22/01/2018
Date last updated
22/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of non-invasive brain stimulation on motor re-learning in people with chronic stroke
Scientific title
The effects of anodal cerebellar transcranial direct current stimulation on locmotor re-learning in people with chronic stroke
Secondary ID [1] 293733 0
Nil known
Universal Trial Number (UTN)
U1111-1200-6805
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 306103 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305229 305229 0 0
Physiotherapy
Stroke 305230 305230 0 0
Haemorrhagic
Stroke 305231 305231 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves four sessions in total: three rehabilitation sessions on a treadmill using transcranial direct current stimulation (tDCS) intervention over three consecutive days and one post-intervention assessment after one week. In the first session, prior to walking on the treadmill, comfortable walking speed and walking asymmetry during over-ground walking will be determined. During treadmill walking, kinematic data will be measured through computerized gait analysis that will record 3-dimensional position data from reflective markers placed on legs. The participant’s walking will be assessed during three phases: 1) baseline phase, where both the belts will move at the same speed for 2 minutes; 2) adaptation phase, where both the belts will move at different speeds for 15 minutes; and 3) de-adaptation phase, where the belts will move at same speed again for 3 minutes. During adaptation phase, tDCS intervention will be delivered by a direct current stimulator (Magstim Co, UK) via electrodes placed on the back of the head (active electrode on the cerebellum) and on the cheek (reference electrode). The current will be slowly ramped up to 2 mA over 30 seconds, held constant at 2 mA for 15 minutes and then decreased over 30 seconds at the end of the stimulation. The primary outcome measure will be step length asymmetry measured at post-intervention assessment after one week. To determine the translation of effects to over-ground walking, over-ground walking asymmetry will be assessed after three days and one week. Each session will take approximately two hours (90 minutes-assessment and setting up, 20 minutes-rehabilitation) and will be held at the Running and Cycling clinic, AUT Millennium Institute.
Intervention code [1] 299988 0
Rehabilitation
Intervention code [2] 299989 0
Treatment: Devices
Comparator / control treatment
The control intervention will be carried out in the same way as the tDCS intervention, except that the participant will not recieve the tDCS stimulation (the delivery of current will stop automatically after 30 seconds). Although the control intervention uses sham tDCS stimulation, the participant will still be walking on the treadmill. Thus, the control is active.
Control group
Active

Outcomes
Primary outcome [1] 304384 0
Effect of tDCS on motor learning: Step length asymmetry on the treadmill. Measured with 3-D gait analysis using force plate data.
Timepoint [1] 304384 0
-Baseline phase of treadmill walking on session 1 and session 4
Primary outcome [2] 304386 0
Cumulative effect of tDCS on motor learning: Step length asymmetry on the treadmill. Measured with 3-D gait analysis using force plate data.
Timepoint [2] 304386 0
-Baseline phase of treadmill walking on session 1, session 2 and session3
Primary outcome [3] 304421 0
Effect of tDCS on transfer of learning: Over ground step length asymmetry. Measured with 3D gait analysis using force plate data.
Timepoint [3] 304421 0
-Before treadmill baseline phase on session 1 and session 4
Secondary outcome [1] 341783 0
Within-session learning: Step length asymmetry on treadmill. Measured with 3D gait analysis using force plate data.
Timepoint [1] 341783 0
-Baseline phase and de-adaptation phase of treadmill walking on session 1
-Baseline phase and de-adaptation phase of treadmill walking on session 2
-Baseline phase and de-adaptation phase of treadmill walking on session 3
Secondary outcome [2] 341784 0
Between-session learning: Step length asymmetry on treadmill. Measured with 3D gait analysis using force plate data.
Timepoint [2] 341784 0
-De-adaptation phase of treadmill walking on session 1 and baseline phase of session 2
-De-adaptation phase of treadmill walking on session 2 and baseline phase of session 3

Eligibility
Key inclusion criteria
-Single stroke causing hemiparesis affecting ability to walk
-More than 6 months post stroke
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-inability to walk for 5 minutes continuously
-cerebellar stroke
-contra-indications to transcranial direct current stimulation

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)
Following recruitment, screening and informed consent, eligible participants will be randomly allocated to either intervention or control group using a randomisation schedule generated by a computer system. This will be held by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation stratified by age, time since stroke and comfortable walking speed
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The effect of tDCS will be assessed by a linear mixed model analysis, with one between-group independent variable as type of stimulation condition (two levels: anodal and sham) and one within-group independent variables as session (four levels: session1, session2, session3 and session4). The dependent variable will consist of mean step length asymmetry at baseline, adaptation, de-adaptation phase and overground walking. Post-hoc tests will only be calculated where the main factor or interaction are significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9473 0
New Zealand
State/province [1] 9473 0
Auckland

Funding & Sponsors
Funding source category [1] 298347 0
University
Name [1] 298347 0
Auckland University of Technology
Address [1] 298347 0
Private Bag 92006
Auckland 1142
Country [1] 298347 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 297467 0
None
Name [1] 297467 0
Address [1] 297467 0
Country [1] 297467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299340 0
Health and Disability Ethics Committees
Ethics committee address [1] 299340 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 299340 0
New Zealand
Date submitted for ethics approval [1] 299340 0
23/08/2017
Approval date [1] 299340 0
12/10/2017
Ethics approval number [1] 299340 0
17/STH/147

Summary
Brief summary
This study aims to find out if passing low continuous electric currents to the cerebellum, a part of the brain at the back of the head, can speed up the acquisition of a lower limb motor task in people with chronic stroke. As the cerebellum plays a major role in adapting and fine tuning movements through a trial and error process, application of non-invasive transcranial direct current stimulation (tDCS) to the cerebellum has been identified as one potential method of promoting motor learning. Research demonstrates that single session of transcranial direct current stimulation (tDCS), when applied to the cerebellum, increases the rate and amount of motor learning in healthy individuals, however, little is known about its effects in people with stroke.
A randomised controlled trial is proposed, where 6 month post-stroke participants will receive the stimulation as they learn to adapt their walking pattern in response to a treadmill that forces one leg to move faster than the other. The participants will be randomised to receive either real anodal tDCS or sham tDCS. A computerised gait analysis system will record their walking on the treadmill which will be used to calculate the primary outcome i.e step length asymmetry. We hypothesize that application of anodal tDCS will result in greater motor learning as compared to the sham stimulation.This information will facilitate the development of novel neuromodulatory interventions that could be used in rehabilitation to reduce the time spent re-learning other motor skills.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80114 0
Dr Nada Signal
Address 80114 0
Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 80114 0
New Zealand
Phone 80114 0
+64 9 921 9999 x 7062
Fax 80114 0
Email 80114 0
nada.signal@aut.ac.nz
Contact person for public queries
Name 80115 0
Dr Nada Signal
Address 80115 0
Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 80115 0
New Zealand
Phone 80115 0
+64 9 921 9999 x 7062
Fax 80115 0
Email 80115 0
nada.signal@aut.ac.nz
Contact person for scientific queries
Name 80116 0
Prof Denise Taylor
Address 80116 0
Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 80116 0
New Zealand
Phone 80116 0
+64 9 921 9680
Fax 80116 0
Email 80116 0
denise.taylor@aut.ac.nz

No data has been provided for results reporting
Summary results
Not applicable