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ARTICLES: B. Dobkin, D. Apple, H. Barbeau, M. Basso, A. Behrman, D. Deforge, J. Ditunno, G. Dudley, R. Elashoff, L. Fugate, S. Harkema, M. Saulino, M. Scott, and the Spinal Cord Injury Locomotor Trial (SCILT) Group Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI Neurology 2006; 66: 484-493 [Abstract] [Full text] [PDF]

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Hugues Barbeau   (3 November 2006)

Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI

Anton Wernig   (7 June 2006)

Reply from the Author

Bruce H. Dobkin, MD   (7 June 2006)

Untitled 3 November 2006
Hugues Barbeau, McGill University Montreal, Quebec, Canada H3G 1Y5 Send Correspondence to journal: Re: this article hugues.barbeau{at}mcgill.ca Hugues Barbeau	The editorial by Dr. Wolpaw highlights the significance of the first multi-randomized clinical trial (MCRCT)for neurorehabilitation after acute spinal cord injury (SCI). [1] Several therapeutic implications of the trial that were not addressed warrant discussion. In this trial, the effect of body weight supported treadmill training (BWSTT) was compared to a control over-ground mobility training (CONT), not to conventional rehabilitation for individuals with incomplete SCI. A large sample of people with typical ASIA B, C, and D injuries received standing and gait training. The experimental arm received BWSTT followed by immediate practice over-ground. Training afforded the sensory-specific experience of walking and emphasized weight-bearing on the legs. The control group received over-ground standing and usual gait training. Both groups received 40-60 training sessions, a higher frequency than is typically provided. The MCRCT demonstrated for the first time that ASIA C and D subjects in both groups achieved significant gains 6 months after study entry. Most subjects attained abilities sufficient for community ambulation including a fast speed (1.0 m/s), relatively good endurance (400m in 6 min) without walking aids and excellent balance (54/56 Berg balance). Therefore, the trial demonstrates that aggressive rehabilitation in the early phase of SCI is likely to benefit a very high percentage of these individuals. Specifically, these results suggest that at least one hr/day of weight- bearing standing and gait training should be emphasized as early as possible for up to 60 sessions, likely resulting in a progressive increase in walking speed over time but this relationship requires further investigation. The findings of the current clinical trial now set the minimum recovery standards by which all new treatments will be compared. Future studies may be obligated to employ a control therapy (defined by either the experimental or control arm) to ensure at least a 90% rate of locomotor recovery consistent with the present trial each of which received substantial weight-bearing step training. The dichotomous training effects for ASIA B compared to ASIA C and D subjects in the present trial indicate that different treatment approaches are warranted for more severely injured individuals. For individuals with ASIA A and B injuries, greater supraspinal input or combination therapies may be necessary in which activity-based therapy is a catalyst for treatments such as spinal cord/muscle stimulation or pharmaceuticals. As plasticity-inducing therapies emerge, specific activity-based therapy may enhance activation and training of the neuromuscular systems. For those persons with ASIA C and D injuries that achieved 1.0 m/s gait speed, more challenging and complex task-specific training targeting balance and adaptability requirements of community conditions may be warranted. Such training might include speed variations, quick stops/starts, obstacle and uneven terrain negotiation. The first MCRCT for neurorehabilitation in acute SCI provides important information towards developing evidence-based practice. Future research for therapies advancing recovery after SCI should address the following questions: Which patient will benefit how much and in what way with a specific type and amount of therapy?; When post-injury should a therapy (or therapies) be delivered?; and What therapy or combination is necessary? References 1. Wolpaw JR. Treadmill training after spinal cord injury: Good but not better Neurology 2006;66:466-467. Disclosure: The authors report no conflicts of interest.
Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI 7 June 2006
Anton Wernig, Phyiology Univ. Bonn and Klinikum Karlsbad-Langensteinbach Wilhelmstrasse 31, 53111 Bonn, Germany Send Correspondence to journal: Re: Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI anton.wernig{at}ukb.uni-bonn.de Anton Wernig	Dobkin et al [1] seemingly failed to detect the superiority of training on the treadmill in acute spinal cord injured (SCI) patients. This outcome is expected considering the study design. In contrast to our controlled trial [2], both the control and the study groups were given the same large amount of specific therapy (i.e., training of upright walking). Without a proper control group, it can not be determined whether the two procedures were better than no therapy at all. In Dobkin et al's "pre-trial" group [3] (collected in the same participating clinics before onset of the trial), only 58% of the initial ASIA C and D patients reached independent walking (from Table 3) [3] but 92% in the trial control (and experimental) group. [1] This highlights the significant therapeutic effect of intensive walking over ground and on the treadmill. These data also confirm the superiority of LB therapy we found with 53% comparable success of "conventional" but 96% of LB-therapy (8/15 but 29/30 spastic patients -Fig.3). [2] The notion concerning our motor score [1] is obsolete since the maximum for both limbs is 80 (not 50), and distance to injury is larger. Our data for the first time demonstrated that aggressive task-related training i.e. intensive up-right walking with well defined rules on the treadmill ("Laufband-LB- therapy", see www.meb.uni-bonn.de/wernig) or over ground (patient Z4) is successful. Dobkin et al's study design is not practical for everyday therapy. Previous praxis found treadmill speeds between 0.1 and some 2.0 km/h effective [2], Dobkin used 3.8 km/h and above as adequate without showing an advantage. To the contrary, the robot-like moving of the limbs might hinder the patient's active contribution and jeopardize activity-related learning. [5] With high speeds--as with over-ground walking non-ambulating ASIA B and C patients--three therapists are needed to handle a single patient instead of one to two. [2] An additional therapist may be available in well-funded trials but difficult in real-life clinical settings. The predictable consequence is a decline in compliance of patients, therapists and financial officers. References 1. Dobkin B, Apple D, Barbeau H, et al. Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI. Neurology 2006;66:484–493. 2. Wernig A, Müller S, Nanassy A, Cagol E. Laufband therapy based on “rules of spinal locomotion” is effective in spinal cord injured persons. Eur J Neurosci 1995;7:823–829 3. Dobkin BH, Apple D, Barbeau H, et al. Methods for a randomized trial of weight- supported treadmill training versus conventional training for walking during inpatient rehabilitation after incomplete traumatic spinal cord injury. Neurorehabil Neural Repair 2003;17: 153–167. 4. Wernig A, Müller S. Laufband locomotion with body weight support improved walking in persons with severe spinal cord injuries. Paraplegia 1992;30:229-38 5. Wernig A, “Ineffectiveness” of Automated Locomotor Training. Arch Phys Med Rehabil 2005; 86: 2385-6 The author has no commercial benefit directly related to this article. Disclosure: The author reports no conflicts of interest.
Reply from the Author 7 June 2006
Bruce H. Dobkin, MD, Department of Neurology, University of California Los Angeles UCLA School of Medicine, RNRC, 710 Westwood Plaza, Los Angeles, CA 90095 Send Correspondence to journal: Re: Reply from the Author bdobkin{at}mednet.ucla.edu Bruce H. Dobkin, MD	We read the comments by Dr. Wernig with interest. Drs. Wernig and Dietz [6] misrepresent the aims of the Spinal Cord Injury Locomotor Trial (SCILT). [1] SCILT is the first multi-center, randomized, parallel group, single-blinded rehabilitation trial of patients with incomplete SCI. We compared two interventions for walking in subjects who could not walk at entry - BWSTT with overground practice vs equivalent practice time for standing and conventional gait training. Patients were consecutively recruited upon admission to six rehabilitation centers (mean 4.5 weeks after onset) and trained for 12 weeks (about 45 hrs). Possibly, we provided more or less therapy than some programs, but to compare two interventions, the treatments had to be of equal intensity.[8] The Wernig study [2] has been called a controlled trial, [2,7] but in contrast to SCILT it used a convenience sample of subjects some of whom did not have traumatic SCI. Wernig compared results of BWSTT to selected "historic controls," which allows for bias, employed unblinded outcomes, and did not test walking speed. Wernig’s design did not allow scientific conclusions about efficacy, but did stimulate the need for SCILT. Neither the Wernig, Dietz, or SCILT clinical trials were designed to test the rules of locomotion.[2] Wernig mistakenly considers our pre-trial observations as equivalent to control data. We stated that one power analysis for SCILT was based on Functional Independence Measure locomotor (FIM-L) scores from inpatient discharges. [3] SCILT trained subjects for about 6 weeks beyond discharge, then measured outcomes at 6 months so pre-trial FIM-L is not comparable to SCILT outcomes. Wernig also suggests that "a proper control group" may be "no therapy" at all. What value to science and patients is a trial that compares a control group seated in wheelchairs to some form of step training? The end result would only support the inferiority of inactivity to task-oriented training. Wernig and Dietz also state that SCILT subjects could walk, whereas treadmill training should only be given to those who cannot load their legs and step.[6] At entry, however, SCILT subjects had no recordable walking speed and their mean FIM-L score was 1 (unable). Wernig also believes that the BWSTT strategy was incorrect, yet both arms of SCILT had the same percentage of walkers that he reported. As an evidence-based practice, then, BWSTT is equivalent to overground training over the first 4 months after incomplete SCI. Trials of interventions for nonwalkers beyond that time are now a logical step. We must recalibrate our attachments to BWSTT,[9] however, during early rehabilitation. References 6. Dietz V. Good clinical practice in neurorehabilitation. Lancet Neurol 2006;5:377-8. 7. Dietz V, Harkema SJ. Locomotor activity in spinal cord-injured persons. J Appl Physiol 2004;96:1954-60. 8. Dobkin BH. Rehabilitation and functional neuroimaging dose-response trajectories for clinical trials. Neurorehabil Neural Repair 2005;19:276- 82. 9. Dobkin B. Overview of treadmill locomotor training with partial body weight support: A neurophysiologically sound approach whose time has come for randomized clinical trials. Neurorehabil Neural Repair 13:157-165. Disclosure: The author reports no conflicts of interest.