Trial Review

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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
Scientific title
A pilot study of cranial nerve non-invasive neuromodulation to improve balance and gait in stroke survivors
Secondary ID [1] 290751 0
None
Universal Trial Number (UTN)
U1111-1190-9249
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 301338 0
Balance impairment 301340 0
Gait impairment 301341 0
Condition category
Condition code
Stroke 301091 301091 0 0
Haemorrhagic
Stroke 301116 301116 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 296655 0
Rehabilitation
Intervention code [2] 296676 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 300507 0
MiniBEST Balance Evaluation Test
Timepoint [1] 300507 0
2 weeks
Secondary outcome [1] 330151 0
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)
Timepoint [1] 330151 0
2 weeks
Secondary outcome [2] 330152 0
COGLOG measure of cognitive function
Timepoint [2] 330152 0
2 weeks
Secondary outcome [3] 330153 0
Depression Anxiety Stress Scale
Timepoint [3] 330153 0
2 weeks
Secondary outcome [4] 330156 0
Canadian Occupational Performance Measure
Timepoint [4] 330156 0
2 weeks
Secondary outcome [5] 330204 0
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.
Timepoint [5] 330204 0
Throughout 2-week intervention period

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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Allocation involves contacting the central administration site to obtain the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Pilot study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/10/2016
Date of last participant enrolment
Anticipated
31/03/2017
Actual
30/04/2017
Date of last data collection
Anticipated
14/04/2017
Actual
12/05/2017
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7130 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 14891 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295177 0
Other
Name [1] 295177 0
Private philanthropy
Country [1] 295177 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan Street
Parkville, VIC 3050
Country
Australia
Secondary sponsor category [1] 294005 0
None
Name [1] 294005 0
Address [1] 294005 0
Country [1] 294005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296526 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 296526 0
C/- Royal Melbourne Hospital
Grattan St
Parkville, VIC. 3050
Ethics committee country [1] 296526 0
Australia
Date submitted for ethics approval [1] 296526 0
22/03/2016
Approval date [1] 296526 0
26/05/2016
Ethics approval number [1] 296526 0
HREC/16/MH/103

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71166 0
Prof Mary Galea
Address 71166 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC. 3010
Country 71166 0
Australia
Phone 71166 0
+61 3 8387 2017
Fax 71166 0
Email 71166 0
[email protected]
Contact person for public queries
Name 71167 0
Mary Galea
Address 71167 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC. 3010
Country 71167 0
Australia
Phone 71167 0
+61 3 8387 2017
Fax 71167 0
Email 71167 0
[email protected]
Contact person for scientific queries
Name 71168 0
Mary Galea
Address 71168 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC. 3010
Country 71168 0
Australia
Phone 71168 0
+61 3 8387 2017
Fax 71168 0
Email 71168 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Epub Sept 20 2017. Galea MP, Cofre Lizama LE, Bas... [More Details]
Plain language summaryNo The group who received tongue stimulation plus int... [More Details]

Documents added automatically
No additional documents have been identified.