Manually assisted body-weight supported locomotor training does not re-establish walking in non-walking subjects with chronic incomplete spinal cord injury: A randomized clinical trial

Abstract

LAY ABSTRACTThis randomized clinical trial assesses the effects of manually assisted body-weight supported treadmill training in patients with chronic functionally incomplete spinal cord injury acquired > 2 years earlier. Due to recruitment challenges, it was only possible to recruit twothirds of the planned number of study participants. The intervention group received gait training 5 days per week over 12 weeks, and the control group received usual care with their local physical therapist. Subjects with no baseline gait function did not regain walking ability. Compared with the control group, the intervention group showed modest improvements in walking speed, lower extremity strength, and body control. However, all between-group differences were non-significant. Because the target number of study participants was not reached, the study was underpowered and non-significant, and thus the findings are inconclusive. It does, however, seem that this training method has benefits, but it is labour-intensive and requires large amounts of human resources. Objective: To assess the effects of manually assisted body-weight supported locomotor training in subjects with chronic incomplete spinal cord injury. Design: Randomized controlled clinical trial. Subjects: Twenty subjects with American Spinal Injury Association Impairment Scale grades C or D and > 2 years post-injury. Methods: Random allocation to 60 days of bodyweight supported locomotor training, or usual care, which might include over-ground walking. Walking function, lower extremity muscle strength and balance were blindly evaluated pre-/post-intervention. Results: A small, non-significant improvement in walking function was observed (0.1 m/s (95% confidence interval ( 95% CI) -0.2, 0.4)), but subjects without baseline gait function, did not re-establish walking. The effect on lower extremity muscle strength was 2.7 points (95% CI -1.4, 6.8). No difference was observed in balance measures. Conclusion: Subjects with chronic incomplete spinal cord injury without baseline walking function were unable to re-establish gait with manually assisted body-weight supported locomotor training. A modest, non-significant, improvement was found in strength and walking speed. However, due to study recruitment problems, an effect size that was smaller than anticipated, and large functional heterogeneity among study subjects, the effect of late-onset body-weight supported locomotor training is not clear. Future studies should include larger numbers of subjects with less functional loss and greater functional homogeneity. Intensive training should probably start earlier post-injury.

Robot-assisted locomotor training did not improve walking function in patients with chronic incomplete spinal cord injury: A randomized clinical trial

“…Compared with our previous study (13), which recruited subjects nationally, subjects in this study were eligible if they lived within 70 km of the training site. Recruitment occurred either from Sunnaas Rehabilitation Hospital or through advertisements in magazines for persons with SCI.…”

“…Subjects should be mainly wheelchair-dependent with or without some walking function, have a body mass index (BMI) < 30, and be cognitively unaffected. Exclusion criteria were conditions that might prevent or conflict with locomotor training (13) or physical limitations for using the robotic device.…”

“…Dynamic balance and postural control were assessed by Berg's Balance Scale (BBS) and the Modified Functional Reach test (MFR), respectively. All tests have been described in detail elsewhere (13).…”

“…Subjects with incomplete SCI with more severe functional deficit also seem to benefit from RALT. However patients without walking function before training are also frequently unable to walk independently after intervention (1,11,13).…”

“…There are little data available regarding late-onset training in subjects severely affected by SCI. We recently published a controlled study on manually assisted weight-supported locomotor training in subjects with chronic incomplete SCI (2+ years post-injury), with severely reduced or no walking function (13). The rationale for the present robot-assisted RCT was to investigate whether a less personnel-demanding robot-assisted training programme would have similar treatment effects as the manually assisted approach in comparison with control groups receiving usual care.…”