Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001172998
Ethics application status
Approved
Date submitted
6/08/2020
Date registered
9/11/2020
Date last updated
9/11/2020
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of exercise and brain stimulation on balance and walking in people at risk of falling: A feasibility study
Scientific title
Noisy galvanic vestibular stimulation (nGVS) combined with balance rehabilitation in older adults with moderate to high falls risk: A feasibility study for an RCT
Secondary ID [1] 301438 0
none
Universal Trial Number (UTN)
U1111-1241-2231
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance impairment
 317740 0
Falls 317741 0
Gait disorder 317755 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315810 315810 0 0
Physiotherapy
Injuries and Accidents 317353 317353 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
Participants will attend a rehabilitation exercise programme delivered in groups of 4-6 older adults by a physiotherapist twice a week for 8 weeks. An attendance record will be kept by the Physiotherapist running the programme.

The exercise programme is a 50 minute, low intensity progressive programme based on standard principles of balance training focussing on the integration of the visual, vestibular and somatosensory systems. Types of exercises in the programme include; standing and walking on unstable surfaces, vestibular ocular habituation (head turning) exercises, and controlling limits of stability (standing with a progressively smaller base of support)- these will all be done at a Borg scale of exertion 11-12 (Exercises that require some exertion but not enough to speed up your breathing). The exercise session will conclude with 5-minutes static cycling at a Borg scale of perceived exertion of around 13 (Requiring moderate effort and speeds up your breathing but doesn’t make you out of breath).

Treatment group participants will complete the exercise programme whilst receiving noisy Galvanic Stimulation (nGVS) for 45 minutes. Participants wear electrodes placed over the mastoid process by either the Physiotherapist or research assistant and attached to a commercially available galvanic stimulator (Softrex Medical). Staff will be trained in the application and use of the nGVS machines by a member of the research team experienced in their use. The nGVS machines are designed for research and will be programmed to the nGVS setting by an unblinded member of the research team and numbered with the participants study number. The nGVS is white noise GVS - a zero-mean random signal with equal intensities at different frequencies. The intensity is set at 0.5mA and is of imperceptable magnitude (the participant is unable to feel or hear the nGVS).

Comparator/ Control group
This study uses a 3-armed randomised double blinded, parallel, control trial design. There will be two groups that control for treatment effect, the sham group and the control group.

The Sham Group will wear electrodes over the mastoid process applied by the Physiotherapist or Research assistant and attached to the galvanic stimulator which has been programmed to the sham setting by the unblinded researcher. As the nGVS is administered at a subsensory level neither the Therapist or participant will know whether they are receiving sham nGVS or nGVS. Sham group participants will partake in the same exercise programme as the treatment group participants. The Control Group will receive no intervention (nGVS or exercise programme) but will be offered the same balance rehabilitation programme as the treatment and sham group after the 6-month follow up assessment.

Intervention code [1] 317749 0
Rehabilitation
Comparator / control treatment
This study uses a 3-armed randomised double blinded, parallel, control trial design. There will be two groups that control for treatment effect, the sham group and the control group.

The Sham Group will wear electrodes over the mastoid process applied by the Physiotherapist or Research assistant and attached to the galvanic stimulator which has been programmed to the sham setting by the researcher. As the nGVS is administered at a subsensory level neither the Therapist or participant will know whether they are receiving sham nGVS or nGVS. Sham group participants will partake in the same exercise programme as the treatment group participants. The Control Group will receive no intervention (nGVS or exercise programme) but will be offered the same balance rehabilitation programme as the treatment and sham group after the 6 month follow up assessment.
Control group
Placebo

Outcomes
Primary outcome [1] 324015 0
Balance: Measured by Centre of Pressure (COP) excursion of a force plate.
Timepoint [1] 324015 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Primary outcome [2] 324016 0
Gait: Gait parameters measured during Single and dual task gait.
Timepoint [2] 324016 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Primary outcome [3] 324017 0
Spatial memory: Triangle Completion task
Timepoint [3] 324017 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Secondary outcome [1] 383549 0
Lower limb strength: 30 second chair stand
Timepoint [1] 383549 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Secondary outcome [2] 383553 0
Acceptability of the treatment: Semi structured interview
Timepoint [2] 383553 0
Week 10 post participant enrolment
Secondary outcome [3] 386533 0
4 Stage Balance test
Timepoint [3] 386533 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Secondary outcome [4] 386534 0
Timed up and go
Timepoint [4] 386534 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Secondary outcome [5] 386535 0
Functional Gait Assessment
Timepoint [5] 386535 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Secondary outcome [6] 386536 0
Activities- specific balance confidence scale
Timepoint [6] 386536 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Secondary outcome [7] 386537 0
4 Mountains Test
Timepoint [7] 386537 0
Week 1, week 10, week 22 and week 36 post participant enrolment
Secondary outcome [8] 387760 0
Feasibility: Recruitment capacity and the resulting sample characteristics:
Number of eligible participants
Drop out rate over intervention and follow up period
Recruitment rate (goal of 2 participants per week for the duration of the study)
Timepoint [8] 387760 0
Week 1, Week 10, Week 22, Week 36
Secondary outcome [9] 387761 0
Feasibility: Data collection procedures and outcome measures
Are the data collection procedures and outcome measures appropriate for the intended population and study aims? For the measure of postural sway which parameter is most sensitive to change and should be selected for the full study? The feasibility of using 3D motion analysis and the value of the data collected from the 3D motion analysis will be investigated. If kinematic variables measuring head movement appear to provide important additional information we will collect in the Full Study.
Timepoint [9] 387761 0
Week 1, Week 10, Week 22, Week 36
Secondary outcome [10] 387762 0
Feasibility: The acceptability and suitability of the intervention and study procedures.
Are the study procedures and interventions suitable and acceptable to participants and physiotherapists? What if any modifications to study procedures and/or intervention are required?
Timepoint [10] 387762 0
Week 1, Week 10, week 22, week 36, Therapist Qualitative interviews.
Secondary outcome [11] 387763 0
Feasibility: A preliminary evaluation of participant responses to the intervention.
Does the intervention show promise at being successful with the intended population? What effect size is found in the Feasibility Study?
Timepoint [11] 387763 0
Week 1, week 10, week 22, week 36

Eligibility
Key inclusion criteria
Community-dwelling adults aged 65 and above or Maori/ Pasifika aged 55 and above at risk of falling according to the STEADI screening tool
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological condition diagnosed by a medical practitioner
A pacemaker or metal implants in the head or neck region
Vertigo
Unable to follow a three step instruction
Unable to stand independently for 5 minutes
Unable to ambulate with or without walking aids for 10 metres

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)
Group allocation is concealed in a sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated group allocation stratified by age, falls history in the past 6 months and number of medications the participant is taking.
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this Feasibility Study there is no intention to formally investigate intervention effectiveness and analysis will focus on descriptive and correlational statistics. Examination of the data at the participant level will be done to determine if changes in key outcome variables occurred.Inspection of the data will inform the Full Study and help refine participant selection, test protocol, and choice of outcomes. Responsiveness metrics such as effect size and standardised response mean will be calculated for postural control outcomes to inform selection of primary outcome and power calculations for the intervention study.

Qualitative data
Patients and therapists will be interviewed at the end of the intervention period using a semistructured format. Interviews will be audio recorded and transcribed verbatim. Data will be analysed in NVivo using methods of constant comparison in which data is examined for similar themes. Initial qualitative findings will acted on during the feasibility study and further interviews undertaken to check if improvements had occurred.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
31/07/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 22655 0
New Zealand
State/province [1] 22655 0
Auckland

Funding & Sponsors
Funding source category [1] 305876 0
Government body
Name [1] 305876 0
Health Research Council of New Zealand
Country [1] 305876 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90 Akoranga Drive
Northcote
Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 306332 0
None
Name [1] 306332 0
Address [1] 306332 0
Country [1] 306332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306136 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 306136 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 306136 0
New Zealand
Date submitted for ethics approval [1] 306136 0
24/06/2020
Approval date [1] 306136 0
22/09/2020
Ethics approval number [1] 306136 0
20/STH/111

Summary
Brief summary
Intact postural control (balance) is essential for safe and effective movement. Age-related decline in postural control threatens everyday activity and reduced levels of mobility, and confidence and increased risk of falls and gait impairment. Evidence suggests that balance training improves mobility, confidence and spatial cognition and reduces falls. A recent advance is the use of sub-sensory threshold noisy galvanic vestibular stimulation (nGVS), which uses galvanic stimulation delivered with a gaussian noise signal to enhance weak sensory input and facilitate information processing in sensory systems. nGVS has been shown to improve postural control, cognition and gait parameters in older adults, people with vestibular disorders and people with Parkinson’s disease.

This study assesses the effect of nGVS to alter balance and gait when delivered in conjunction with a group balance rehabilitation programme. Using nGVS to augment a balance programme is a novel use of this technology. If effective, this has the potential to enhance the effect of balance retraining reducing the profound and significant sequale of reduced mobility and falls to health.

The Feasibility Study aim is to evaluate trial processes to determine if the design is feasible. A secondary aim is to evaluate the outcome measures to inform the design of a full RCT and also participant opinions of the intervention to refine the Full Study protocol. The aim of a subsequent Full Study is to determine if an 8 week balance rehabilitation programme augmented with noisy galvanic stimulation (nGVS) is effective in improving postural stability compared to either the balance programme with a sham nGVS or a no intervention control in older adults with moderate to high falls risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102834 0
Prof Denise Taylor
Address 102834 0
Auckland University of Technology
90 Akoranga Drive.
Northcote.
Auckland 0627
Country 102834 0
New Zealand
Phone 102834 0
+64 09 9219999
Fax 102834 0
Email 102834 0
[email protected]
Contact person for public queries
Name 102835 0
Prof Denise Taylor
Address 102835 0
Auckland University of Technology
90 Akoranga Drive.
Northcote.
Auckland 0627
Country 102835 0
New Zealand
Phone 102835 0
+64 09 9219999
Fax 102835 0
Email 102835 0
[email protected]
Contact person for scientific queries
Name 102836 0
Prof Denise Taylor
Address 102836 0
Auckland University of Technology
90 Akoranga Drive.
Northcote.
Auckland 0627
Country 102836 0
New Zealand
Phone 102836 0
+64 09 9219999
Fax 102836 0
Email 102836 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.