Abstract
BackgroundRehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed extremities, promotes neurological improvement. The aim of this study is to compare the effects of a 12-week intensive activity-based therapy program for the whole body with a program of upper body exercise.Methods/DesignA multicenter, parallel group, assessor-blinded randomized controlled trial will be conducted. One hundred eighty-eight participants with spinal cord injury, who have completed their primary rehabilitation at least 6 months prior, will be recruited from five SCI units in Australia and New Zealand. Participants will be randomized to an experimental or control group. Experimental participants will receive a 12-week program of intensive exercise for the whole body, including locomotor training, trunk exercises and functional electrical stimulation-assisted cycling. Control participants will receive a 12-week intensive upper body exercise program. The primary outcome is the American Spinal Injuries Association (ASIA) Motor Score. Secondary outcomes include measurements of sensation, function, pain, psychological measures, quality of life and cost effectiveness. All outcomes will be measured at baseline, 12 weeks, 6 months and 12 months by blinded assessors. Recruitment commenced in January 2011.DiscussionThe results of this trial will determine the effectiveness of a 12-week program of intensive exercise for the whole body in improving neurological recovery after spinal cord injury.Trial registrationNCT01236976 (10 November 2010), ACTRN12610000498099 (17 June 2010).
Highlights
Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence
The results of this trial will determine the effectiveness of a 12-week program of intensive exercise for the whole body in improving neurological recovery after spinal cord injury
No formal interim analyses for efficacy or futility are planned. This trial will provide information about the effectiveness of an intensive full-body exercise program in promoting neurological improvement. This is important for understanding the therapeutic effect of rehabilitation independent of drug or cellular interventions, since rehabilitation may confound the outcome of these interventions [45]
Summary
This trial will provide information about the effectiveness of an intensive full-body exercise program in promoting neurological improvement. This is important for understanding the therapeutic effect of rehabilitation independent of drug or cellular interventions, since rehabilitation may confound the outcome of these interventions [45]. The control intervention is not standard care but an active intervention, involving an intensive exercise program for the upper body. This ensures that the intensity and group dynamics of the both exercise programs are similar, so that the effects of adding exercise of the paralyzed lower limbs can be identified.
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