RecruitingPhase 3ACTRN12612000003875

Does standing improve bowel function in people with spinal cord injury? A randomised controlled trial.

Sponsor

Rehabilitative Studies Unit

Enrollment

20 participants

Start Date

Dec 1, 2011

Study Type

Interventional

Conditions

Neurogenic bowel dysfuntion in spinal cord injury.

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether regular standing (using a tilt table) improves bowel function in people with spinal cord injury (SCI). Many people with SCI have serious bowel problems, including constipation and incontinence, which they often find more disabling than not being able to walk. While many people with SCI believe standing helps, there is no strong scientific evidence yet. This study randomly assigns participants to a standing program or no standing, and measures changes in bowel function over time. You may be eligible if: - You are 18 years or older - You have a traumatic spinal cord injury or spinal lesion above the T8 level (classified as AIS A or B — meaning no or minimal movement/sensation below the injury) - Your injury occurred more than one year ago - Your bowel routine is stable - You are medically stable and able to stand on a tilt table (with or without a carer's help) - You live in the Sydney metropolitan area You may NOT be eligible if: - You are pregnant - You have a history of bowel disease, bowel surgery, or a stoma - You have osteoporosis or have had osteoporotic fractures (unless you have medical clearance) - You are already regularly standing or walking and are not wheelchair-dependent (unless willing to stop for 2 months) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 stan

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.

Locations(1)

Australia

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ACTRN12612000003875