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J Rehabil Med 2019; 51: 113–119 ORIGINAL REPORT 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 Anu PIIRA, PT, MPH 1,2 , Anne M. LANNEM, PT, PhD 3 , Marit SØRENSEN, PhD 4 , Thomas GLOTT, MD 3 , Raymond KNUTSEN, MD, MPH 2,5 , Lone JØRGENSEN, PT, PhD 1,6 , Knut GJESDAL, MD, PhD 7 , Nils HJELTNES, MD, PhD 3 and Synnøve F. KNUTSEN, MD, PhD 2,5 From the 1 Department of Health and Care, Arctic University of Norway, Tromsø, 2 North Norway Rehabilitation Center, Tromsø, 3 Sunnaas Rehabilitation Hospital, Nesodden, 4 Department of Coaching and Psychology, Norwegian School of Sport Sciences, Oslo, Norway, 5 Department of Epidemiology and Biostatistics, Loma Linda University, Loma Linda, CA, USA, 6 Department of Clinical Therapeutic Services, University Hospital of Northern Norway, Tromsø, and 7 Department of Cardiology, Oslo University Hospital Ullevål and Institute of Clinical Medicine, University of Oslo, Oslo, Norway Objective: To assess the effects of manually assisted body-weight supported locomotor training in sub- jects 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 body- weight supported locomotor training, or usual care, which might include over-ground walking. Walking function, lower extremity muscle strength and ba- lance were blindly evaluated pre-/post-intervention. Results: A small, non-significant improvement in walking function was observed (0.1 m/s (95% con- fidence 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 dif- ference was observed in balance measures. Conclusion: Subjects with chronic incomplete spi- nal cord injury without baseline walking function were unable to re-establish gait with manually as- sisted 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 smal- ler than anticipated, and large functional heterogen- eity 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 fun- ctional homogeneity. Intensive training should pro- bably start earlier post-injury. Key words: spinal cord injury; locomotor training; body- weight support; treadmill. Accepted Oct 23, 2018; Epub ahead of print Nov 28, 2018 J Rehabil Med 2019; 51: 113–119 Correspondence address: Anu Piira, North Norway Rehabilitation Cen- ter, Conrad Holmboes veg 95, NO-9011 Tromsø, Norway. E-mail: anu. [email protected] B ody-weight supported locomotor training (BWSLT) has been used to retrain walking func­ LAY ABSTRACT This randomized clinical trial assesses the effects of ma- nually assisted body-weight supported treadmill training in patients with chronic functionally incomplete spinal cord injury acquired > 2 years earlier. Due to recruit- ment challenges, it was only possible to recruit two- thirds 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 abi- lity. 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. Be- cause the target number of study participants was not reached, the study was underpowered and non-signi- ficant, 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. tion after spinal cord injury (SCI) after experimental SCI in animals (1) and in uncontrolled human clinical studies (2–8). Both older (2, 3) and more recent studies (4–8) have reported encouraging results. Locomotor gait training increased muscle volume (7), improved activation of muscles in the lower limbs (9), increased ankle stability (10), and was associated with decreased spasticity (11). There is also some evidence that BWSLT improves subjects’ wellbeing and quality of life (6), and the benefits seem to be sustained (12). A 2017 review concluded that, so far, locomotor training has not proven more effective in restoring walking speed and distance walked than the same amount of conventional gait training in patients with SCI (13). Spontaneous improvement in SCI can occur up to 2 years post-injury (14), blurring the effects of train- ing in studies in the early post-injury phase. Such an effect attenuation may explain the null findings of a large multicentre randomized controlled trial (RCT) (n = 146) with subjects enrolled 8 weeks after injury (15). On the other hand, early intervention may be This is an open access article under the CC BY-NC license. www.medicaljournals.se/jrm Journal Compilation © 2019 Foundation of Rehabilitation Information. ISSN 1650-1977 doi: 10.2340/16501977-2508