Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000003875
Ethics application status
Approved
Date submitted
1/12/2011
Date registered
3/01/2012
Date last updated
3/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does standing improve bowel function in people with spinal cord injury? A randomised controlled trial.
Scientific title
Does standing improve bowel function in people with spinal cord injury? A randomised controlled trial.
Secondary ID [1] 262555 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurogenic bowel dysfuntion in spinal cord injury. 268219 0
Condition category
Condition code
Physical Medicine / Rehabilitation 268347 268347 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six weeks of standing on a tilt table for 30 minutes, five times a week, superimposed on regular bowel care routine.

A tilt table is a piece of rehabilitative equipment that allows a person to stand. The tilt table used for this trial is electrically operated with tilt angles varying between 0 to 90 degrees. There are safety straps that secure the person's upper and lower body on the tilt table. Participants will trial standing on the tilt table with one of the research team members prior to the start of the treatment-first phase. Training and education will be provided to the participants and their carers prior to commencing the standing program.

Regular bowel care routine is the routine a participant uses to assist emptying the bowels. The frequency and duration of the routine differs between individuals.

This is a crossover study. Participants allocated to the treatment-first group will receive the treatment first consisting of six weeks of standing superimposed on a regular bowel routine. This will be followed by four weeks of washout period where the participant does not stand but continues with regular bowel routine, then the control intervention, namely six weeks of regular bowel routine. Participants allocated to the control-first group will receive the opposite: six weeks of regular bowel routine but no standing, four weeks of washout period and then six weeks of standing superimposed on a regular bowel routine.
Intervention code [1] 266891 0
Rehabilitation
Comparator / control treatment
Six weeks of no standing. The participant continues to receive regular bowel care routine.
Control group
Active

Outcomes
Primary outcome [1] 269120 0
Time taken to evacuate the first stool as assessed by a blinded assessor.
Timepoint [1] 269120 0
On two occasions within the same week at baseline and at 6, 10, and 16 weeks after commencement in the trial. The average of the two measures taken at the time frame will be used for analysis.
Secondary outcome [1] 276964 0
Neurogenic bowel dysfunction as assessed using the Neurogenic Bowel Dysnfunction Score.
Timepoint [1] 276964 0
At baseline and at 6, 10, and 16 weeks after commencement in the trial.
Secondary outcome [2] 276965 0
Clinical assessment of constipation as assessed using the Cleveland Constipation Score.
Timepoint [2] 276965 0
At baseline and at 6, 10, and 16 weeks after commencement in the trial.
Secondary outcome [3] 276966 0
Severity of fecal incontinence as assessed using the St. Mark's Incontinence Score.
Timepoint [3] 276966 0
At baseline and at 6, 10, and 16 weeks after commencement in the trial.
Secondary outcome [4] 276967 0
The total time taken to complete the bowel routine as assessed by a blinded assessor.
Timepoint [4] 276967 0
On two occasions within the same week at baseline and at 6, 10, and 16 weeks after commencement in the trial. The average of the two measures will be taken for analysis.
Secondary outcome [5] 276968 0
The total time taken to complete the bowel routine as recorded by the participant or their carer in a diary.
Timepoint [5] 276968 0
Over the last two weeks of each intervention period.
Secondary outcome [6] 276969 0
The time taken to evacuate the first stool as recorded by the participant or their carer in a diary.
Timepoint [6] 276969 0
Over the last two weeks of each intervention period.

Eligibility
Key inclusion criteria
Participants will be included if they:
- are more than 18 years of age
- have sustained a AIS A or B traumatic spinal cord injury or spinal lesion above T8
- are more than one year post onset of spinal cord injury or lesion
- have a stable bowel regime that is unlikely to change in the near future
- are medically stable to participate in standing
- can independently transfer themselves into standing position on the tilt table or have a carer to assist them
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
- are pregnant
- have a current or past history of bowel disease
- have had surgery of the bowel
- have a stoma
- are unwilling to comply with the standing regime
- do not live in the Sydney metropolitan area
- are unable to speak sufficient English to participate in the study without the assistance of a translator
- are regularly standing and/or walking and not wheelchair-dependent unless they are willing to stop standing for two months prior to the commencement of the trial
- have a current or past history of osteoporosis and/or osteoporotic fracture(s) unless medical clearance is attained

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)
A sample of convenience will be used. Physiotherapists or nurses from Sydney spinal injury units or the Spinal Outreach Service of NSW will directly contact potential participants. Interested participants will undergo a screening by the principal investigator for suitability. Once a potential participant is screened and deemed suitable, the participant will be randomly allocated to one of two treatment sequences using the principles of concealed allocation. Participants allocated to the “treatment first” group will receive the treatment first consisting of six weeks of standing superimposed on a regular bowel routine. This will be followed by four weeks of washout period and then the control intervention, namely six weeks of regular bowel routine. Participants allocated to the “control first” group will receive the opposite: six weeks of regular bowel routine, four weeks of washout period and then six weeks of standing superimposed on a regular bowel routine.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 not otherwise involved in the study. Once a participant has completed the initial assessment, the researcher will contact the central office to attain the participant’s allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267451 0
Other
Name [1] 267451 0
NSW Lifetime Care and Support Authority
Country [1] 267451 0
Australia
Primary sponsor type
Other
Name
Rehabilitative Studies Unit
Address
Northern Clinical School
Sydney School of Medicine
University of Sydney
PO Box 6
Ryde NSW 1680
Country
Australia
Secondary sponsor category [1] 266496 0
None
Name [1] 266496 0
Address [1] 266496 0
Country [1] 266496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269351 0
Royal Rehabilitation Centre Sydney Human Research Ethics Committee
Ethics committee address [1] 269351 0
PO Box 6
Ryde NSW 1680
Ethics committee country [1] 269351 0
Australia
Date submitted for ethics approval [1] 269351 0
24/02/2011
Approval date [1] 269351 0
07/09/2011
Ethics approval number [1] 269351 0
EC00133

Summary
Brief summary
The majority of individuals with spinal cord injury (SCI) have neurogenic bowel dysfunction. Severity of the condition is dependent upon the completeness and the level of lesion. Constipation and faecal incontinence are common problems experienced by individuals with SCI and have significant impact on their physical, social and psychological lives. People with SCI rate bowel care as one of the most disabling aspects of SCI and of more importance to them than the inability to walk. It is therefore appropriate that research attention be directed at improving bowel care.

People with SCI claim that regular standing improves bowel regularity and bowel function. However, there is no high quality evidence to substantiate these claims. A recent Cochrane review noted that there is still limited research on the management of neurogenic bowel dysfunction and it is not possible to draw any recommendation from the trials included in the review. It is important to determine whether regular standing is therapeutic because it is a costly and time consuming activity. Hence the primary aim of this study is to determine the benefits of regular standing on bowel function in people with spinal cord injury or lesion. The null hypothesis is that regular standing will have no effect on bowel function in people with spinal cord injury or lesion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32826 0
Address 32826 0
Country 32826 0
Phone 32826 0
Fax 32826 0
Email 32826 0
Contact person for public queries
Name 16073 0
Lisa Harvey
Address 16073 0
Rehabilitation Studies Unit
Northern Clinical School
Sydney School of Medicine
University of Sydney
PO Box 6, Ryde NSW 1680
Country 16073 0
Australia
Phone 16073 0
+61 2 9809 9099
Fax 16073 0
Email 16073 0
lisa.harvey@sydney.edu.au
Contact person for scientific queries
Name 7001 0
Lisa Harvey
Address 7001 0
Rehabilitation Studies Unit
Northern Clinical School
Sydney School of Medicine
University of Sydney
PO Box 6, Ryde NSW 1680
Country 7001 0
Australia
Phone 7001 0
+61 2 9809 9099
Fax 7001 0
Email 7001 0
lisa.harvey@sydney.edu.au

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA Case-based Reasoning (CBR) model for integrating insurance policy and regulations in a United States physical therapist educational program2015https://doi.org/10.1016/j.physio.2015.03.3350
N.B. These documents automatically identified may not have been verified by the study sponsor.