Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001139864
Ethics application status
Approved
Date submitted
24/10/2012
Date registered
26/10/2012
Date last updated
25/07/2014
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
n/A
Universal Trial Number (UTN)
N/A
Trial acronym
i-FIMS
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

Intervention/exposure
Study type
Interventional
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
Prevention
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
Active

Outcomes
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

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

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)
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
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2012
Actual
27/03/2013
Date of last participant enrolment
Anticipated
Actual
17/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286140 0
Charities/Societies/Foundations
Name [1] 286140 0
Neuroscience Research Australia
Country [1] 286140 0
Australia
Primary sponsor type
Individual
Name
Professor Stephen Lord
Address
Neuroscience Research Australia
Hospital Road
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 285012 0
Individual
Name [1] 285012 0
Professor Simon Gandevia
Address [1] 285012 0
Neuroscience Research Australia
Hospital Road
Randwick NSW 2031
Country [1] 285012 0
Australia
Other collaborator category [1] 277139 0
Individual
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
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288194 0
University of New South Wales (UNSW)
Ethics committee address [1] 288194 0
HREC/UNSW
UNSW Australia
High Street
Kensington, NSW 2052
Australia
Ethics committee country [1] 288194 0
Australia
Date submitted for ethics approval [1] 288194 0
01/11/2012
Approval date [1] 288194 0
08/11/2012
Ethics approval number [1] 288194 0

Summary
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

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

Hospital Road

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

Hospital Road

Randwick NSW 2031
Country 9001 0
Australia
Phone 9001 0
+61 2 9399 1061
Fax 9001 0
+61 2 9399 1204
Email 9001 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3938Plain language summaryNo In summary, the step training system was safe and ... [More Details]
4385Study results articleYes Mult Scler. 2016 Jan;22(1):94-103. doi: 10.1177/13... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of a home-based step training programme on balance, stepping, cognition and functional performance in people with multiple sclerosis - A randomized controlled trial.2016https://dx.doi.org/10.1177/1352458515579442
N.B. These documents automatically identified may not have been verified by the study sponsor.