Journal of Rehabilitation Medicine 51-5 | Page 69

J Rehabil Med 2019; 51: 385–389 SHORT COMMUNICATION ROBOT-ASSISTED LOCOMOTOR TRAINING DID NOT IMPROVE WALKING FUNCTION IN PATIENTS 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 Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, 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 North 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 robot-assisted lo- comotor training in patients with chronic incomplete spinal cord injury. Design: Randomized single-blind controlled clinical trial. Setting: The intervention site was an outpatient clinic, and pre- and post-evaluations were perfor- med in a rehabilitation hospital. Patients: A total of 24 subjects with American Spinal Injury Association Impairment Scale grades C or D, > 2 years post-injury. Interventions: Subjects were randomized to 60 days of robot-assisted locomotor training, or to usual care. Methods: Walking function, lower extremity muscle strength and balance were assessed single-blinded pre- and post-intervention. Results: After a 9-year recruitment period, only 24 of the planned 30 subjects had been enrolled (mean time since injury 17 (standard deviation (SD) 20) years for all subjects). Walking function, lower ex- tremity muscle strength and balance improved mo- destly in both groups, with no statistically signifi- cant group difference in walking function or muscle strength, whereas postural control declined signifi- cantly in the intervention group, compared with con- trols (p  = 0.03). Conclusion: Late-onset robot-assisted locomotor training did not re-establish independent walking function. A modest, but non-significant, effect was seen on muscle strength and balance. However, sig- nificant between-group differences were found only in postural control in the control group. Key words: spinal cord injury; robot-assisted locomotor training; gait; treadmill. Accepted Mar 12, 2019; Epub ahead of print Mar 21, 2019 J Rehabil Med 2019; 51: 385–389 Correspondence address: Anu Piira, North Norway Rehabilitation Cen- ter, Conrad Holmboes veg 95, NO-9011 Tromsø, Norway. E-mail: anu. [email protected] V arious locomotor training methods have been used in attempts to recover walking function LAY ABSTRACT This randomized clinical trial assesses the effects of ro- bot-assisted treadmill training in persons with chronic incomplete spinal cord injury acquired > 2 years earlier. Due to recruitment challenges, it was possible to re- cruit only 63% of the planned number of participants. The intervention group received gait training 3 days per week for a period of 6 months and the control group received usual care with their local physical therapist. The intervention group showed improvements in lo- wer extremity strength and balance, but no change in walking function. Significant between-group difference was found only in postural control, favouring the control group. Because the target number of study participants was not reached, the study was underpowered and non- significant, and thus the findings are inconclusive. This training method may have benefits, but the robotic de- vice is expensive and training effects are limited when the person’s baseline function is poor and the training starts late in incomplete spinal cord injury. after spinal cord injury (SCI). Older (1, 2) and more recent studies (3–7) have reported promising results by using robotics to recover gait. A review from 2017 concluded that robot-assisted locomotor training (RALT) had effects similar to other types of body- weight-supported locomotor training, and to the same amount of conventional training or physical therapy (8), in re-establishing walking independence and en- durance/distance walked. A number of randomized controlled trials (RCTs) using robotic walking therapy have been conducted with varying types of control groups, degree of injury, time since injury, site of the lesion, and varying number and length of the training sessions (3–7, 9–11). These and other factors, such as use of anti-spastic medica- tion, all seem to influence the outcome. Several RCTs have compared different intensive training forms in subjects with chronic or subacute SCI. However, these studies control groups did not receive “usual care”. Rather, the control groups received other interventions, such as over-ground gait training with or without functional electrostimulation (4, 11), conven- 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: 10.2340/16501977-2547