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Trial registered on ANZCTR


Registration number
ACTRN12616001053415
Ethics application status
Approved
Date submitted
26/07/2016
Date registered
5/08/2016
Date last updated
31/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An interactive step training system to reduce falls in people with multiple sclerosis: a randomised controlled trial
Scientific title
An interactive step training system to reduce falls in people with multiple sclerosis: a randomised controlled trial
Secondary ID [1] 289177 0
Nil known
Universal Trial Number (UTN)
Trial acronym
i-FIMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 298716 0
Falls 298717 0
Sleep quality 299084 0
Muscle performance 299085 0
Condition category
Condition code
Neurological 298769 298769 0 0
Multiple sclerosis
Injuries and Accidents 298770 298770 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of balance and step training delivered through a novel home-based step-training system (smart +/- step). The system involves a computerised training mat measuring approximately one square metre with eight step panels and connected to a visual display (television or computer screen) that displays training instructions and game-based stepping exercises. The exercises will be tailored to the participant's abilities for the duration of the trial.

STUDY PROTOCOL
* During an initial home visit, a trained researcher (exercise physiologist or physiotherapist) will set up and demonstrate the 'smart +/- step' step-training system, ensuring the participant can use the equipment safely on their own. This visit is expected to take approximately 60-90 minutes.
* A follow up home visit will be scheduled approximately four weeks following the initial home visit to ensure participant safety during exercise, progression of the training and to discuss any issues relating to use of the program. This visit is expected to take approximately 30 minutes.
* Dose of exercise training will be at least 120 minutes per week during the 6-month intervention period. Participants are able to determine the frequency and duration of each exercise session according to their preference.
* Participant adherence (training volume, frequency) will be monitored through automatic data transfer to a server, and will be examined weekly. Participants not engaging in the minimum weekly training dose for 2 consecutive weeks will be contacted by telephone to discuss any issues and to encourage adherence during the 6-month intervention period.
* Phone support will be available and additional home visits will be offered as needed/requested for the entire duration of the study.
Intervention code [1] 294703 0
Prevention
Intervention code [2] 295441 0
Treatment: Devices
Comparator / control treatment
Control group participants will receive usual care in the form of a booklet containing general information about exercise and mobility aids
Control group
Active

Outcomes
Primary outcome [1] 298457 0
Proportion of fallers in each study group: falls will be monitored with monthly falls diaries for 12 months after baseline assessment.
Timepoint [1] 298457 0
6 months after baseline assessment
Primary outcome [2] 298459 0
The rate of falling in each study group: Falls will be monitored with monthly falls diaries for 12 months after baseline assessment.
Timepoint [2] 298459 0
6 months after baseline assessment
Secondary outcome [1] 324205 0
The proportion of fallers in each group: Falls will be monitored with monthly falls diaries for the 12 months after baseline assessment
Timepoint [1] 324205 0
12 months after baseline assessment
Secondary outcome [2] 324562 0
The rate of fallers in each group: Falls will be monitored with monthly falls diaries for the 12 months after baseline assessment
Timepoint [2] 324562 0
12 months after baseline assessment
Secondary outcome [3] 324563 0
Static and dynamic balance will be measured using the swaymeter device from the Physiological Profile Assessment
Timepoint [3] 324563 0
At baseline assessment and at 6 month reassessment
Secondary outcome [4] 324564 0
Clinical measures of lower leg strength will be measured using a dynamometer
Timepoint [4] 324564 0
At baseline assessment and 6-month reassessment
Secondary outcome [5] 324565 0
Clinical measures of gait (velocity and distance) will be assessed with the 10-metre and 6-minute walk tests
Timepoint [5] 324565 0
At baseline assessment and 6-month reassessment
Secondary outcome [6] 324567 0
Clinical measures of stepping will be measured using the Choice Stepping Reaction Time (CSRT) tests
Timepoint [6] 324567 0
At baseline assessment and 6-month reassessment
Secondary outcome [7] 324568 0
MS disease severity will be measured using the Multiple Sclerosis Functional Composite (MSFC)
Timepoint [7] 324568 0
At baseline assessment and 6-month reassessment
Secondary outcome [8] 324569 0
Questionnaire measure of concern about falling using the Iconographical Falls Efficacy Scale
Timepoint [8] 324569 0
At baseline assessment and 6-month reassessment
Secondary outcome [9] 324570 0
Questionnaire measure of physical activity levels using the Incidental Planned Exercise Questionnaire
Timepoint [9] 324570 0
At baseline assessment and 6-month reassessment
Secondary outcome [10] 324571 0
Cognition measured using the Trails A and Trails B tests
Timepoint [10] 324571 0
At baseline assessment and 6-month reassessment
Secondary outcome [11] 324572 0
Questionnaire measure of quality of life using the European Quality of Life - 5 Dimensions and World Health Organisation Disability Assessment Schedule 2.0
Timepoint [11] 324572 0
At baseline assessment and 6-month reassessment
Secondary outcome [12] 324573 0
Questionnaire measure of mood using the Patient Health Questionnaire-9
Timepoint [12] 324573 0
At baseline assessment and 6-month reassessment
Secondary outcome [13] 324574 0
Questionnaire measure of fatigue using the Modified Fatigue Impact Scale
Timepoint [13] 324574 0
At baseline assessment and 6-month reassessment
Secondary outcome [14] 324648 0
Cost-effectiveness of the intervention measured by data linkage to fall-related medical health records
Timepoint [14] 324648 0
At 6 and 12 months after baseline assessment
Secondary outcome [15] 324649 0
Movement detection threshold about the ankle joint measured using a motorised foot plate designed for this study
Timepoint [15] 324649 0
At baseline assessment and 6-month reassessment
Secondary outcome [16] 324650 0
Maximal isometric voluntary force of the calf muscles measured with surface electrodes
Timepoint [16] 324650 0
At baseline assessment and 6-month assessment
Secondary outcome [17] 324654 0
Measures of sleep disruption using a take-home sleep testing device. Home testing will be performed using either a standard Type 2 (e.g. Nox A1 Polysomnography system) or Type 3 (e.g. ResMed ApneaLink plus) device.
Timepoint [17] 324654 0
Baseline assessment and 6-month reassessment
Secondary outcome [18] 324655 0
Questionnaire measures of sleepiness and sleep quality using the Epworth Sleepiness Scale, Functional outcomes of sleep questionnaire, Karolinska sleepiness scale, and Pittsburgh sleepiness scale
Timepoint [18] 324655 0
Baseline assessment and 6-month reassessment
Secondary outcome [19] 324656 0
Screening questionnaires for the presence of sleep apnoea measured using the STOP BANG, Berlin sleep questionnare, and OSA50
Timepoint [19] 324656 0
At baseline assessment and 6-month reassessment
Secondary outcome [20] 326160 0
Joint position sense about the ankle joint measured using a motorised foot plate designed for this study
Timepoint [20] 326160 0
At baseline assessment and 6-month reassessment
Secondary outcome [21] 326161 0
Reaction time to small movements about the ankle joint using a motorised foot plate designed for this study
Timepoint [21] 326161 0
At baseline assessment and 6-month reassessment
Secondary outcome [22] 326162 0
Voluntary activation of the calf muscles using twitch interpolation and measured with surface electrodes
Timepoint [22] 326162 0
At baseline assessment and 6-month reassessment
Secondary outcome [23] 326163 0
Twitch force of the calf muscles elicited by electrical stimulation and measured with surface electrodes
Timepoint [23] 326163 0
At baseline assessment and 6-month reassessment
Secondary outcome [24] 326164 0
Fatigue of the calf muscles with a sustained isometric contraction measured with electrical muscle stimulation and surface electrodes
Timepoint [24] 326164 0
At baseline assessment and 6-month reassessment
Secondary outcome [25] 326168 0
Daily life walking patterns measured with a wearable physical activity monitor over a seven day period
Timepoint [25] 326168 0
At baseline assessment and 6-month reassessment
Secondary outcome [26] 326184 0
Sit to stand transitions measured with a wearable physical activity monitor over a seven day period
Timepoint [26] 326184 0
At baseline assessment and 6-month reassessment
Secondary outcome [27] 326185 0
Number of near falls, slips or trips measured with a wearable physical activity monitor over a seven day period
Timepoint [27] 326185 0
At baseline assessment and 6-month reassessment
Secondary outcome [28] 326186 0
Total energy expenditure from activities of daily living measured with a wearable physical activity monitor over a seven day period
Timepoint [28] 326186 0
At baseline assessment and 6-month reassessment
Secondary outcome [29] 326187 0
Sedentary time measured with a wearable physical activity monitor over a seven day period
Timepoint [29] 326187 0
At baseline assessment and 6-month reassessment
Secondary outcome [30] 326188 0
Daily life sleeping patterns measured with a wearable physical activity monitor over a seven day period
Timepoint [30] 326188 0
At baseline assessment and 6-month reassessment
Secondary outcome [31] 326189 0
Dual task cost assessed with a dual task and 10-metre walk
Timepoint [31] 326189 0
Baseline assessment and 6-month reassessment

Eligibility
Key inclusion criteria
* Aged 18 years and over
* Living in the community
* Confirmed diagnosis of Multiple Sclerosis (MS)
* Expanded Disability Status Scale (EDSS) between 2 and 6
* No apparent cognitive impairment, being able to understand and follow test instructions
* Stable MS (with or without disease-modifying drugs) with no exacerbation in the past 30 days
* Currently not involved in any falls prevention exercise research trials
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to perform the Choice Stepping Reaction Time test
* Unable to walk 10 metres without bilateral mobility aid
* Existing conditions that prevent exercise (e.g. severe pain, heel ulcers, severe spasticity, excessive fatigue, exercise intolerance) or have been advised by a medical doctor not to exercise
* Relapse of MS in the past 30 days

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following completion of baseline assessment, participants will be randomised using a web-based randomisation service performed centrally. i.e. a concealed randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation via an external web-based randomisation service, conducted centrally.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Analyses will be conducted with an intention-to-treat approach. The number of falls per person-year will be analysed using negative binomial regression to estimate the difference in falls rates between the two groups. General linear models will be used to assess the effect of group allocation on the continuously scored secondary outcome measures.

Based on the fall rate from our current study we estimate a fall rate in the control arm of this study will be 50%. We further estimate that the intervention will
reduce the number of fallers in relative terms by 30% in this period (or 15% in absolute terms). Consequently, accounting for dropouts (10%), a power of 80% and a 5% significance level, a total sample size of 500 is required

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/08/2016
Actual
23/08/2016
Date of last participant enrolment
Anticipated
30/08/2019
Actual
Date of last data collection
Anticipated
29/11/2019
Actual
Sample size
Target
500
Accrual to date
110
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA

Funding & Sponsors
Funding source category [1] 293789 0
Government body
Name [1] 293789 0
National Health and Medical Research Council
Country [1] 293789 0
Australia
Primary sponsor type
Individual
Name
Professor Stephen Lord
Address
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 292623 0
Individual
Name [1] 292623 0
Doctor Phu Hoang
Address [1] 292623 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country [1] 292623 0
Australia
Other collaborator category [1] 279021 0
Individual
Name [1] 279021 0
Professor Simon Gandevia
Address [1] 279021 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country [1] 279021 0
Australia
Other collaborator category [2] 279022 0
Individual
Name [2] 279022 0
Professor Rob Herbert
Address [2] 279022 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country [2] 279022 0
Australia
Other collaborator category [3] 279023 0
Individual
Name [3] 279023 0
Associate Professor Janet Taylor
Address [3] 279023 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country [3] 279023 0
Australia
Other collaborator category [4] 279024 0
Individual
Name [4] 279024 0
Associate Professor Danny Eckert
Address [4] 279024 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country [4] 279024 0
Australia
Other collaborator category [5] 279025 0
Individual
Name [5] 279025 0
Associate Professor Michael Barnett
Address [5] 279025 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country [5] 279025 0
Australia
Other collaborator category [6] 279096 0
Individual
Name [6] 279096 0
Doctor Daina Sturnieks
Address [6] 279096 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country [6] 279096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295174 0
Human Research Ethics Committee of the University of New South Wales
Ethics committee address [1] 295174 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 295174 0
Australia
Date submitted for ethics approval [1] 295174 0
Approval date [1] 295174 0
01/04/2015
Ethics approval number [1] 295174 0
HC14211
Ethics committee name [2] 295175 0
Human Research Ethics Committee of the Prince of Wales Hospital
Ethics committee address [2] 295175 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
RANDWICK NSW 2031
Ethics committee country [2] 295175 0
Australia
Date submitted for ethics approval [2] 295175 0
Approval date [2] 295175 0
13/04/2015
Ethics approval number [2] 295175 0
14/312

Summary
Brief summary
Falls are common among people with multiple sclerosis (MS). About 60% of people with MS (PwMS) experience at least one fall each 6 months and about 30% have multiple falls.
Increased fall risk and fear of falls have been shown to significantly affect quality of life
and curtail activities among people with MS. Therefore, effective interventions to reduce
fall risk in PwMS are urgently needed.

Fall prevention and treatment strategies in MS are still at an early stage. Studies on falls in
MS reveal important balance, coordination and cognitive determinants of falls. Based on
these results, we propose a randomised single-blind controlled trial (RCT) to
evaluate a step training intervention designed to prevent falls in PwMS. The proposed
trial will enrol approximately 500 PwMS over a period of 36 months. Recruitment will initially take place in NSW and will be extended to other Australian states if required.

It is expected that if the research confirms effectiveness of treatment strategies,
implementation of clinical interventions will contribute to reduced fall rates in PwMS and
associated injury-associated costs, reduced fear of falls and improved quality of life for
PwMS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65742 0
Prof Stephen Lord
Address 65742 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country 65742 0
Australia
Phone 65742 0
+61 2 9399 1061
Fax 65742 0
Email 65742 0
s.lord@neura.edu.au
Contact person for public queries
Name 65743 0
Stephen Lord
Address 65743 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country 65743 0
Australia
Phone 65743 0
+61 2 9399 1061
Fax 65743 0
Email 65743 0
s.lord@neura.edu.au
Contact person for scientific queries
Name 65744 0
Stephen Lord
Address 65744 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country 65744 0
Australia
Phone 65744 0
+61 2 9399 1061
Fax 65744 0
Email 65744 0
s.lord@neura.edu.au

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No Supporting Document Provided



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