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Trial registered on ANZCTR


Registration number
ACTRN12606000415505
Ethics application status
Approved
Date submitted
21/09/2006
Date registered
25/09/2006
Date last updated
21/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a 6-week program of intensive balance training improve the abiility of people with spinal cord injuries to perform functional tasks.
Scientific title
Does a 6-week program of intensive balance training improve the abiility of people with spinal cord injuries to perform functional tasks.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 1384 0
Condition category
Condition code
Neurological 1476 1476 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly allocated to either a treatment or control group. The treatment group will exercise with a research physiotherapist for 60-minutes, 3 days a week for 6 weeks. The 60 minutes will be spent practicing particular tasks whilst seated. At the beginning and end of the 6-week period the subjects ability to sit balanced will be assessed.
Intervention code [1] 1370 0
Rehabilitation
Comparator / control treatment
The control group will receive no intervention for the 6 week period.
Control group
Active

Outcomes
Primary outcome [1] 2045 0
Upper Body Sway Distance
Timepoint [1] 2045 0
At baseline and 6 weeks.
Primary outcome [2] 2047 0
Maximal balance range test
Timepoint [2] 2047 0
At baseline and 6 weeks.
Primary outcome [3] 2049 0
T-shirt test
Timepoint [3] 2049 0
At baseline and 6 weeks.
Primary outcome [4] 3380 0
Canadian Occupational Performance Measure (COPM) - performance component
Timepoint [4] 3380 0
Baseline, 6 weeks
Secondary outcome [1] 3528 0
Canadian Occupational Performance Measure (COPM) - importance and satisfaction components
Timepoint [1] 3528 0
Baseline, 6 weeks
Secondary outcome [2] 3529 0
Modified falls efficacy scale
Timepoint [2] 3529 0
Baseline, 6 weeks
Secondary outcome [3] 5600 0
Alternating Reach Test in supported and unsupported conditions
Timepoint [3] 5600 0
Baseline, 6 weeks
Secondary outcome [4] 5601 0
Upper Body Sway in anteroposterior and lateral directions
Timepoint [4] 5601 0
Baseline, 6 weeks
Secondary outcome [5] 5602 0
Coordinated Stability Test
Timepoint [5] 5602 0
Baseline, 6 weeks
Secondary outcome [6] 5603 0
Self perception rating of balance when holding on, not holding on and fear of falling
Timepoint [6] 5603 0
Baseline, 6 weeks
Secondary outcome [7] 5604 0
Self reported number of falls
Timepoint [7] 5604 0
Baseline, 6 weeks
Secondary outcome [8] 5605 0
Seated Reach Distance 45 degrees to right
Timepoint [8] 5605 0
Baseline, 6 weeks

Eligibility
Key inclusion criteria
Spinal cord injury between T1 and T12 (ASIA A, B or C with no greater than a total motor score of 5 for each lower limb); injury at least one year prior to inclusion in the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pain or spasm affecting the ability to sit unsupported; pressure areas on the sacrum or ishial tuberosities.

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)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessor and data analyst blinded
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 1615 0
Government body
Name [1] 1615 0
NSW Premier's Spinal Cord Injury Grant Program
Address [1] 1615 0
Governor Macquarie Tower 1 Farrer Pl Sydney 2000
Country [1] 1615 0
Australia
Funding source category [2] 1616 0
Government body
Name [2] 1616 0
National Health and Medical Research Council of Australia
Address [2] 1616 0
GPO Box 1421 Canberra ACT 2601
Country [2] 1616 0
Australia
Primary sponsor type
Other
Name
Prince of Wales Medical Research Institute
Address
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 1417 0
University
Name [1] 1417 0
Rehabilitation Studies Unit and University of Sydney
Address [1] 1417 0
PO Box 6
Ryde NSW 1680
Country [1] 1417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3064 0
Royal Rehabilitation Centre Sydney
Ethics committee address [1] 3064 0
Ethics committee country [1] 3064 0
Australia
Date submitted for ethics approval [1] 3064 0
Approval date [1] 3064 0
11/04/2005
Ethics approval number [1] 3064 0
05/01
Ethics committee name [2] 3065 0
Human Research Ethics Committee - Eastern Section
Ethics committee address [2] 3065 0
Ethics committee country [2] 3065 0
Australia
Date submitted for ethics approval [2] 3065 0
Approval date [2] 3065 0
26/08/2005
Ethics approval number [2] 3065 0
05/123

Summary
Brief summary
The primary purpose of this study is to determine the most effective way of improving the ability of people with spinal cord injuries to balance and sit unsupported. We hope to learn whether an intensive 6-week balance-training program improves the ability of people with established spinal cord injuries to balance and perform functional tasks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27597 0
Address 27597 0
Country 27597 0
Phone 27597 0
Fax 27597 0
Email 27597 0
Contact person for public queries
Name 10559 0
Mrs Claire Boswell-Ruys
Address 10559 0
Prince of Wales Medical Research Institute
Barker Street
Randwick NSW
2031
Country 10559 0
Australia
Phone 10559 0
(02) 9399 1029
Fax 10559 0
(02) 9399 1027
Email 10559 0
claire.boswell-ruys@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1487 0
Dr Lisa Harvey
Address 1487 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6
Ryde, NSW
1680
Country 1487 0
Australia
Phone 1487 0
(02) 98099099
Fax 1487 0
(02) 98099037
Email 1487 0
l.harvey@usyd.edu.au

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