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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Balance Exercise for multiple sclerosis
Scientific title
Exercise to improve balance and reduce fall risk in people with multiple sclerosis – a pilot randomized controlled trial
Secondary ID [1] 281390 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
reduced balance 287623 0
Multiple sclerosis 287702 0
Condition category
Condition code
Neurological 287953 287953 0 0
Multiple sclerosis

Study type
Description of intervention(s) / exposure
Interactive stepping exercises on purpose-built stepping mat connected to television. Participants will perform stepping in a random manner as indicated on the screen. Time to complete that task will be recorded (similar to a wii game). Data on exercises will be transmitted wirelessly to database for future analysis. Participants are requested to practice 30 minutes/day, 3 times/week for 12 weeks.
Intervention code [1] 285866 0
Intervention code [2] 285948 0
Treatment: Devices
Comparator / control treatment
normal care involves strengthening exercises for lower limb muscles, stretching, and balance exercises. Type and number of exercises are individualised by a physiotherapist, who provides home visit, depending on participants condition and ability. Frequency: 3 x/week, 30 minutes/session
Control group

Primary outcome [1] 288163 0
Choice stepping reaction time (CSRT): on a mat with 6 rectangles, 4 in lower row and 2 at front row, participants start by standing with the feet inside the middle 2 rectangles in lower row. Participants are instructed to step randomly to the right side or left side or to front with either left or right foot. Tester uses a standard list of instructions. Time to complete list is recorded.
Timepoint [1] 288163 0
Week 0 and week 12
Primary outcome [2] 288164 0
STROOP stepping test (Participants stand in the centre of the dance mat used for training and in the centre of a computer screen an arrow will be presented pointing in one of four directions (up, down, left, right). Inside the arrow is a written word in a high contrast colour indicating a different direction. Participants are instructed to step according to the word and by doing that to selectively attend to one stimulus and inhibit the response indicated by the arrow's shape)
Timepoint [2] 288164 0
Week 0 and week 12
Primary outcome [3] 288165 0
Co-ordinated stability: Participants perform the coordinated stability test (2 attempts) barefoot trying to control a swaymeter strapped around the waist to trace a 'butterfly' shape. The number of corner and side errors are recorded from. The better attempt in the outcome measure is recorded.
Timepoint [3] 288165 0
Week 0 and week 12
Secondary outcome [1] 299539 0
10-meter Walk test
Timepoint [1] 299539 0
Week 0 and week 12
Secondary outcome [2] 299692 0
number of falls during trial period
Timepoint [2] 299692 0
12 weeks

Key inclusion criteria
EDSS = 2-7, stabilised MS, history of falls, no apparent cognitive problems
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
EDSS > 7, limited English, cognitive impairment, ataxia,

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
50 participants will be recruited from those with multiple sclerosis living metropolitan Sydney, Australia. A block-randomisation procedure will be applied to form two groups with similar size. Randomisation will be undertaken by a staff member not involved with the study using a computer-generated list of random numbers. Personnel administering the assessments will be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block-randomisation procedure will be applied
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286140 0
Name [1] 286140 0
Neuroscience Research Australia
Address [1] 286140 0
Hospital Road
Randwick NSW 2031
Country [1] 286140 0
Primary sponsor type
Professor Stephen Lord
Neuroscience Research Australia
Hospital Road
Randwick NSW 2031
Secondary sponsor category [1] 285012 0
Name [1] 285012 0
Professor Simon Gandevia
Address [1] 285012 0
Neuroscience Research Australia
Hospital Road
Randwick NSW 2031
Country [1] 285012 0
Other collaborator category [1] 277139 0
Name [1] 277139 0
Dr Phu Hoang
Address [1] 277139 0
Multiple Sclerosis Australia ACT/NSW/VIC

80 Betty Cuthbert Drive

Lidcombe NSW 2141
Country [1] 277139 0

Ethics approval
Ethics application status
Ethics committee name [1] 288194 0
University of New South Wales (UNSW)
Ethics committee address [1] 288194 0
UNSW Australia
High Street
Kensington, NSW 2052
Ethics committee country [1] 288194 0
Date submitted for ethics approval [1] 288194 0
Approval date [1] 288194 0
Ethics approval number [1] 288194 0

Brief summary
In our recent study we found that ~ 60% of people with MS experienced one or more fall during 6-month follow up and 31% fell 3+ times. This is consistent with previous reports. High rates of falls in MS are significantly associated with poor performance in clinical balance tests, especially stepping ability. There is limited information on balance training in MS. Here, we propose to use an interactive step training system as a home-based exercise program to improve balance and consequently prevent fall risk in MS. The interactive system has been developed by our group and has been shown to have beneficial to older adults. This will be a pilot study to prepare for a larger randomised controlled trial to formally evaluate potential fall-related health benefits of interactive step training system use by people with MS.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34826 0
Dr Phu Hoang
Address 34826 0
Neuroscience Research Australia, Barker St, Randwick NSW 2031
Country 34826 0
Phone 34826 0
+61 2 93991832
Fax 34826 0
Email 34826 0
Contact person for public queries
Name 18073 0
Dr Dr Phu Hoang
Address 18073 0
Neuroscience Research Australia

Hospital Road

Randwick NSW 2031
Country 18073 0
Phone 18073 0
+61 2 9399 1000
Fax 18073 0
Email 18073 0
Contact person for scientific queries
Name 9001 0
Prof Prof. Stephen Lord
Address 9001 0
Neuroscience Research Australia

Hospital Road

Randwick NSW 2031
Country 9001 0
Phone 9001 0
+61 2 9399 1061
Fax 9001 0
+61 2 9399 1204
Email 9001 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary