Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000464369
Ethics application status
Approved
Date submitted
16/09/2008
Date registered
17/09/2008
Date last updated
30/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Training unsupported sitting in people with spinal cord injuries: a randomized controlled trial
Scientific title
Skill-based training of unsupported sitting in people with spinal cord injuries
Secondary ID [1] 283465 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury (SCI) 3703 0
Condition category
Condition code
Neurological 3868 3868 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects in the experimental group will receive an intensive training program specifically directed at improving their ability to sit unsupported. The training will be based on the principles of motor learning and administered three times a week for 30 minutes over a six-week period.
Intervention code [1] 3415 0
Rehabilitation
Comparator / control treatment
Subjects in the control group will continue to receive usual care but will not receive more than three 5-minute sessions a week of therapy directed at improving their ability to sit unsupported. Usual care will include standard physiotherapy and occupational therapy as provided as part of inpatient rehabilitation in Sydney spinal injury units.
Control group
Active

Outcomes
Primary outcome [1] 4769 0
Maximal forward lean (cm) from a seated upright position.
Timepoint [1] 4769 0
pre and post (1 day after last treatment)
Primary outcome [2] 4770 0
Maximal sideward reach (mm) from a seated upright position.
Timepoint [2] 4770 0
pre and post (1 day after last treatment)
Primary outcome [3] 4771 0
Canadian Outcome Performance Measure (performance outcome). This is a standardised assessment in which subjects rate self-selected goals with respect to their current ability to perform the goal. An 11-point visual analogue scale will be used where zero reflects a negative perception about their ability to perform the goal and ten reflects a positive perception. The change score from pre to post of each goal will be calculated.
Timepoint [3] 4771 0
pre and post (1 day after last treatment)
Secondary outcome [1] 8057 0
Perceptions of change by subjects.
At the end of the trial all subjects will be required to rate the change in their ability to sit unsupported from the beginning of the trial to the end of the trial using the Clinical Global Impression of Change scale.
Timepoint [1] 8057 0
pre and post (1 day after last treatment)
Secondary outcome [2] 8058 0
Canadian Outcome Performance Measure (satisfaction outcome).
This assesses subjects perceptions about treatment effectiveness.
Timepoint [2] 8058 0
pre and post (1 day after last treatment)
Secondary outcome [3] 8059 0
Perceptions of change by therapists based on video footage. Blinded therapists will be required to view pre and post video footage and rate change using the Clinical Global Impression of Change Scale.
Timepoint [3] 8059 0
pre and post (1 day after last treatment)
Secondary outcome [4] 8060 0
T-shirt test (sec).
This test assesses subjects' ability to perform a functional task while sitting unsupported (i.e., put on a T-shirt).
Timepoint [4] 8060 0
pre and post (1 day after last treatment)
Secondary outcome [5] 8061 0
SCI Specific Falls Efficacy Scale
This is a 16-point scale which has been adopted from a similar scale for able-bodied individuals.
Timepoint [5] 8061 0
pre and post (1 day after last treatment)

Eligibility
Key inclusion criteria
1. have sustained a spinal cord injury within the preceding 6 months
2. have a complete or an incomplete spinal cord below the first thoracic level (as per the International Standards for the Neurological Assessment of people wiht SCI)
3. attain a score of 5 or less on the sitting balance item of the COVS (i.e., have some potential to improve)
4. are able to put a T-shirt either in short or long sitting (i.e., are likely to respond to the training)
5. are receiving physiotherapy and occupational therapy as part of a comprehensive in-patient rehabilitation program
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. have a pressure area preventing them from getting out of bed
2. are unlikely to remain in the spinal unit for sixweeks
3. are unlikely to co-operate

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)
All consecutive patients admitted to the Spinal Unit will be screened and invited to participate in the study. Participants will be randomly allocated to either an experimental or control group using the principles of concealed allocation.
An independent person will use a computer to generate a random number sequence. These will be placed in sealed opaque envelopes and kept off-site by a person no otherwise involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer to generate a random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2008
Actual
18/09/2008
Date of last participant enrolment
Anticipated
Actual
26/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1617 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment outside Australia
Country [1] 5539 0
Bangladesh
State/province [1] 5539 0
Dhaka

Funding & Sponsors
Funding source category [1] 3881 0
Hospital
Name [1] 3881 0
Royal Rehabilitation Centre Sydney
Country [1] 3881 0
Australia
Primary sponsor type
University
Name
Rehabilitation Studies Unit, Northen Clinical School, Faculty of Medicine, University of Sydney
Address
PO Box 6, Ryde, NSW, 1680
Country
Australia
Secondary sponsor category [1] 3485 0
Hospital
Name [1] 3485 0
Royal Rehabilitation Centre Sydney
Address [1] 3485 0
PO Box 6, Ryde, NSW, 1680
Country [1] 3485 0
Australia
Other collaborator category [1] 414 0
Hospital
Name [1] 414 0
Spinal Unit, Prince of Wales Hospital
Address [1] 414 0
High St, Randwick, NSW, 2031
Country [1] 414 0
Australia
Other collaborator category [2] 277667 0
Hospital
Name [2] 277667 0
Centre for Rehabilitation of the Paralysed
Address [2] 277667 0
PO CRP-Chapain
Savar
Dhaka 1343
Bangladesh
Country [2] 277667 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5933 0
Royal Rehabilitation Centre Sydney
Ethics committee address [1] 5933 0
PO Box 6, Ryde, NSW, 1680
Ethics committee country [1] 5933 0
Australia
Date submitted for ethics approval [1] 5933 0
Approval date [1] 5933 0
19/12/2007
Ethics approval number [1] 5933 0
07/02

Summary
Brief summary
The aim of this single blind randomized controlled trial is to determine the effectiveness of an intensive training program directed at improving the ability of people with spinal cord injury to sit unsupported. Subjects from Sydney's two spinal injury units will be randomly allocated to an experimental or control condition. Experimental subjects will receive an intensive training program specifically directed at improving their ability to sit unsupported. Control subjects will receive usual care. Subjects’ ability to sit unsupported will be assessed by a blinded therapist at the beginning and end of the study with a standardized battery of tests. In addition, subjects’ and therapists’ impressions about the effectiveness of therapy will be assessed using rating scales designed for this purpose.
Trial website
Trial related presentations / publications
Harvey LA, Ristev D, Hossain MS, Hossain MA, Bowden JL, Boswell-Ruys CL, Hossain MM and Ben M. (2011) Training unsupported sitting does not improve ability to sit in people with recently-acquired paraplegia: a randomised controlled trial. Journal of Physiotherapy, 57, 83-90.

Hossain MS, Harvey LA, Ristev D, Bowden J, Hossain MM (2011) Training unsupported sitting in people with recently-acquired paraplegia: a randomized controlled trial. International Conference on Spinal Cord Medicine and Rehabilitation, Washington, USA.

Ben M, Harvey LA, Ristev D, Hossain MS, Hossain MA, Bowden JL, Boswell-Ruys CL, Hossain MM (2011). Training unsupported in people with recently acquired paraplegia: a randomized controlled trial. Australia and New Zealand Spinal Cord Society (ANZCoS), Brisbane, Australia.

Hossain MS, Hossain MA Hossain MM, Momen KM, Ristev D, Bowden J and Harvey L (2011) Training unsupported sitting in people with recently-acquired paraplegia: a randomized controlled trial. ASCoN, Colombo, Sri Lanka.
Public notes

Contacts
Principal investigator
Name 28941 0
Prof Lisa Harvey
Address 28941 0
John Walsh Centre for Rehabilitation Research
The University of Sydney, Kolling Institute
Royal North Shore Hospital
St Leonards, NSW, 2065
Country 28941 0
Australia
Phone 28941 0
+61 2 9926 4594
Fax 28941 0
+61 2 9926 4045
Email 28941 0
[email protected]
Contact person for public queries
Name 12098 0
Prof Lisa Harvey
Address 12098 0
John Walsh Centre for Rehabilitation Research
The University of Sydney, Kolling Institute
Royal North Shore Hospital
St Leonards, NSW, 2065
Country 12098 0
Australia
Phone 12098 0
+61 2 9926 4594
Fax 12098 0
+61 2 9926 4045
Email 12098 0
[email protected]
Contact person for scientific queries
Name 3026 0
Prof Lisa Harvey
Address 3026 0
John Walsh Centre for Rehabilitation Research
The University of Sydney, Kolling Institute
Royal North Shore Hospital
St Leonards, NSW, 2065
Country 3026 0
Australia
Phone 3026 0
+61 2 9926 4594
Fax 3026 0
+61 2 99264045
Email 3026 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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