Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001074189
Ethics application status
Approved
Date submitted
22/07/2019
Date registered
5/08/2019
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of anodal cerebellar transcranial direct current stimulation on learning a novel walking task in healthy adults.
Scientific title
Cerebellar transcranial direct current stimulation for learning a novel split-belt treadmill task in healthy adults: A randomised controlled trial.
Secondary ID [1] 298802 0
None
Universal Trial Number (UTN)
U1111-1237-3564
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor learning 313753 0
Condition category
Condition code
Neurological 312157 312157 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 312158 312158 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a total of four data collection sessions: the first three sessions held on consecutive days (without any gap between the sessions) and the last follow up session conducted after a gap of one week.The intervention constitutes three consecutive sessions of active anodal cerebellar transcranial direct current stimulation (ctDCS) in conjunction with split-belt treadmill (SBT) walking.The first session will involve completion of screening, consent and the recording of fastest comfortable walking speed on the treadmill which will determine the speed of the two belts of the SBT, such that the belts move at a ratio of 2:1. During SBT 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 10 minutes. During the adaptation phase, active anodal ctDCS intervention will be delivered by a direct current stimulator (Magstim Co, UK) adminstered by a doctoral research student. The active elecrode will be placed on the back of the head (lateral cerebellum) and the reference electrode will be on the cheek (buccinator muscle). 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. Motor performance and strides to steady-state performance will be evaluated before (baseline), during (adaptation) and after (de-adaptation) the intervention. The outcomes will be measured one week later to assess absolute learning and during the three intervention sessions to evaluate cumulative, between and within-session effects. Each session will take approximately 80 minutes (50 minutes- assessment and setting up, 27 minutes SBT walking).
Intervention code [1] 315071 0
Treatment: Other
Intervention code [2] 315132 0
Treatment: Devices
Comparator / control treatment
The control intervention will be carried out in the same way as the ctDCS intervention, except that the participant will not receive the ctDCS stimulation (the delivery of current will stop automatically after 30 seconds). Although the control intervention uses sham ctDCS stimulation, the participant will still be walking on the SBT. Thus, the control is active.
Control group
Active

Outcomes
Primary outcome [1] 320801 0
Motor learning constituting motor performance and strides to steady-state motor performance.
Motor performance will be measured based on step length symmetry during specified time periods during the adaptation and de-adaptation phases.
The strides to steady-state motor performance will be determined by the number of strides taken to achieve steady-state performance where the respective stride remains within the mean ± 2 standard deviations of the last 100 strides for 30 strides.
Timepoint [1] 320801 0
Follow-up one week later
Secondary outcome [1] 372886 0
Cumulative effect will be determined by comparing motor performance and strides to steady-state performance across session1 and session 3.

Motor performance will be measured based on step length symmetry during specified time periods during the adaptation and de-adaptation phases.
The strides to steady-state motor performance will be determined by the number of strides taken to achieve steady-state performance where the respective stride remains within the mean ± 2 standard deviations of the last 100 strides for 30 strides.
Timepoint [1] 372886 0
Session 1 and session 3
Secondary outcome [2] 372887 0
Between-session effect will be determined by comparing motor performance and strides to steady-state performance between session 1 and session 2.
Motor performance will be measured based on step length symmetry during specified time periods during the adaptation and de-adaptation phases.
The strides to steady-state motor performance will be determined by the number of strides taken to achieve steady-state performance where the respective stride remains within the mean ± 2 standard deviations of the last 100 strides for 30 strides.
Timepoint [2] 372887 0
Session 1 and session 2
Secondary outcome [3] 372888 0
Between-session effect will be determined by comparing motor performance and strides to steady-state performance between session 2 and session 3.
Motor performance will be measured based on step length symmetry during specified time periods during the adaptation and de-adaptation phases.
The strides to steady-state motor performance will be determined by the number of strides taken to achieve steady-state performance where the respective stride remains within the mean ± 2 standard deviations of the last 100 strides for 30 strides.
Timepoint [3] 372888 0
Session 2 and session 3
Secondary outcome [4] 372893 0
Within-session effect will be determined by motor performance and strides to steady-state performance at session 1, 2 or 3.
Motor performance will be measured based on step length symmetry during specified time periods during the adaptation and de-adaptation phases.
The strides to steady-state motor performance will be determined by the number of strides taken to achieve steady-state performance where the respective stride remains within the mean ± 2 standard deviations of the last 100 strides for 30 strides.
Timepoint [4] 372893 0
Session 1, session 2, session 3

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of orthopedic, cardiac or neurological conditions that could interfere with walking, and any contraindications to the application of ctDCS.

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)
Pseudo-random number generator in MATLAB 2015a (MathWorks Inc.)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed effects regression model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
18/01/2017
Date of last data collection
Anticipated
Actual
1/02/2017
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 21706 0
New Zealand
State/province [1] 21706 0
Auckland

Funding & Sponsors
Funding source category [1] 303359 0
University
Name [1] 303359 0
Auckland University of Technology
Country [1] 303359 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] 303389 0
None
Name [1] 303389 0
Address [1] 303389 0
Country [1] 303389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303889 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [1] 303889 0
Ethics committee country [1] 303889 0
New Zealand
Date submitted for ethics approval [1] 303889 0
02/09/2016
Approval date [1] 303889 0
10/10/2016
Ethics approval number [1] 303889 0
16/338

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95138 0
Dr Nada Signal
Address 95138 0
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 95138 0
New Zealand
Phone 95138 0
+64 9 921 7062
Fax 95138 0
Email 95138 0
[email protected]
Contact person for public queries
Name 95139 0
Nitika Kumari
Address 95139 0
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 95139 0
New Zealand
Phone 95139 0
+64 9 921 7863
Fax 95139 0
Email 95139 0
[email protected]
Contact person for scientific queries
Name 95140 0
Denise Taylor
Address 95140 0
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 95140 0
New Zealand
Phone 95140 0
+64 9 921 9680
Fax 95140 0
Email 95140 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.