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Trial registered on ANZCTR
Registration number
ACTRN12617000013369
Ethics application status
Approved
Date submitted
13/12/2016
Date registered
5/01/2017
Date last updated
21/08/2019
Date data sharing statement initially provided
21/08/2019
Date results information initially provided
21/08/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
A pilot study of tongue stimulation to improve balance and gait in stroke survivors
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Scientific title
A pilot study of cranial nerve non-invasive neuromodulation to improve balance and gait in stroke survivors
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Secondary ID [1]
290751
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None
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Universal Trial Number (UTN)
U1111-1190-9249
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
stroke
301338
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Balance impairment
301340
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Gait impairment
301341
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Condition category
Condition code
Stroke
301091
301091
0
0
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Haemorrhagic
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Stroke
301116
301116
0
0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants with recent stroke will given sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) through a device called the Portable Neuromodulation Stimulator (PoNS). and concurrent intensive balance and gait training, in addition to usual rehabilitation. The battery-operated PoNS device is worn around the neck and has a mouthpiece with a hexagonally patterned array of gold-plated circular electrodes that goes into the mouth, resting on the top of the tongue, and is held lightly in place by the lips and teeth. The tongue stimulation is provided concurrently with balance and gait training, and the intensity of stimulation can be adjusted for comfort. Participants will attend for treatment with an experienced physiotherapist twice daily for 1.5 hours, 5 days per week for 2 weeks.
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Intervention code [1]
296655
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Rehabilitation
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Intervention code [2]
296676
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Treatment: Devices
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Comparator / control treatment
The control group will be participants with recent stroke who will be given intensive balance and gait training in addition to usual rehabilitation.
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Control group
Active
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Outcomes
Primary outcome [1]
300507
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MiniBEST Balance Evaluation Test
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Assessment method [1]
300507
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Timepoint [1]
300507
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2 weeks
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Secondary outcome [1]
330151
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Gait assessments, including The Timed Up-and-Go Test and overground walking while wearing inertial sensors at the wrists, ankles, sternum and waist (Mobility Lab System, APDM, Inc. Portland OR)
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Assessment method [1]
330151
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Timepoint [1]
330151
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2 weeks
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Secondary outcome [2]
330152
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COGLOG measure of cognitive function
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Assessment method [2]
330152
0
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Timepoint [2]
330152
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2 weeks
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Secondary outcome [3]
330153
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Depression Anxiety Stress Scale
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Assessment method [3]
330153
0
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Timepoint [3]
330153
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2 weeks
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Secondary outcome [4]
330156
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Canadian Occupational Performance Measure
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Assessment method [4]
330156
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Timepoint [4]
330156
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2 weeks
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Secondary outcome [5]
330204
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Adverse events, These may include headaches, clenched jaw leading to temporomandibular joint dysfunction, excessive salivation, or excessive fatigue. Adverse events will be assessed by interviewing the participant at each intervention session.
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Assessment method [5]
330204
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Timepoint [5]
330204
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Throughout 2-week intervention period
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Eligibility
Key inclusion criteria
1. Aged between 18 and 75 years
2. Diagnosis of stroke
3. Admitted for inpatient rehabilitation at the Royal Park Rehabilitation Centre
4. Have sufficient cognitive capacity to participate in this study (ascertained by the rehabilitation consultant).
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Major co-morbidities, especially other neurological disorders, uncontrolled pain, uncontrolled hypertension, brittle diabetes etc.
2. Oral health problems (e.g. gum disease, active cankers etc.) or a history of oral cancer, precluding them from safe participation in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the central administration site to obtain the group allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
Pilot study
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A t-test will be used to compare the difference between groups on change in the primary outcome measure (miniBEST). Exploratory analyses will be conducted using t-tests or Mann-Whitney U tests to compare the groups on the secondary outcome measures.
For this study of 10 participants, missing data will be ignored (assuming that they are missing at random) and only the available data will be analysed.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
3/10/2016
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Date of last participant enrolment
Anticipated
31/03/2017
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Actual
30/04/2017
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Date of last data collection
Anticipated
14/04/2017
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Actual
12/05/2017
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Sample size
Target
10
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
7130
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Royal Melbourne Hospital - Royal Park campus - Parkville
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Recruitment postcode(s) [1]
14891
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3052 - Parkville
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Funding & Sponsors
Funding source category [1]
295177
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Other
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Name [1]
295177
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Private philanthropy
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Address [1]
295177
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c/- Royal Melbourne Hospital Foundation
Royal Melbourne Hospital
Parkville, VIC 3050
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Country [1]
295177
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Australia
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Primary sponsor type
Hospital
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Name
Royal Melbourne Hospital
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Address
Grattan Street
Parkville, VIC 3050
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Country
Australia
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Secondary sponsor category [1]
294005
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None
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Name [1]
294005
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Address [1]
294005
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Country [1]
294005
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296526
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
296526
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C/- Royal Melbourne Hospital
Grattan St
Parkville, VIC. 3050
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Ethics committee country [1]
296526
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Australia
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Date submitted for ethics approval [1]
296526
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22/03/2016
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Approval date [1]
296526
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26/05/2016
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Ethics approval number [1]
296526
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HREC/16/MH/103
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Summary
Brief summary
Many people with stroke have walking and balance dysfunction. Sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) provided through a device called the Portable Neuromodulation Stimulator (PoNS) can stimulate regions in the brain that are important for balance and gait. This study will be a preliminary randomised controlled trial (RCT) of the PoNS combined with a structured task-specific rehabilitation program in stroke survivors undergoing inpatient rehabilitation.The study will be registered with the Therapeutic Goods Administration under the Clinical Trial Notification Scheme (device trial). Ten participants will be randomised to either a 2-week intensive balance and gait training program with a physiotherapist while using the PoNS (intervention), or to a 2-week intensive balance and gait training program with a physiotherapist only (control). Both the intervention and control programs will be conducted at the Royal Park Rehabilitation Centre, and will be additional to the patients' usual rehabilitation program. Training sessions will be tailored to the needs of each participant and comprise five main components: movement control, balance, gait, cognition and breathing and relaxation. Participants will be assessed on a range of outcome measures related to gait and balance, as well as self-perception of performance, depression, cognition and oculomotor function. Assessments will occur at baseline and post-intervention. The primary outcome measures will be the miniBEST Test, which assesses balance. This study will be the first systematic study of the PoNS in Australia, and will establish the safety and preliminary efficacy of the PoNS/training protocol. It will also provide data on which to base a sample size calculation for a future larger RCT.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
71166
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Prof Mary Galea
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Address
71166
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Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC. 3010
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Country
71166
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Australia
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Phone
71166
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+61 3 8387 2017
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Fax
71166
0
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Email
71166
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[email protected]
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Contact person for public queries
Name
71167
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Prof Mary Galea
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Address
71167
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Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC. 3010
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Country
71167
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Australia
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Phone
71167
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+61 3 8387 2017
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Fax
71167
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Email
71167
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[email protected]
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Contact person for scientific queries
Name
71168
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Prof Mary Galea
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Address
71168
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Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC. 3010
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Country
71168
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Australia
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Phone
71168
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+61 3 8387 2017
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Fax
71168
0
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Email
71168
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Epub Sept 20 2017. Galea MP, Cofre Lizama LE, Bas...
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Plain language summary
No
The group who received tongue stimulation plus int...
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Documents added automatically
No additional documents have been identified.
Download to PDF