Over-ground and robotic-assisted locomotor training in adults with chronic stroke: a blinded randomized clinical trial

Purpose: The purpose was to compare the effectiveness of robotic-assisted body weight supported treadmill training using the Lokomat® to over-ground gait training (OGT) in adults with chronic stroke. Methods: Participants were randomly assigned to the Lokomat® or OGT interventions. Both protocols included 40 sessions over 8 weeks. Primary outcome measures were the 10-meter walk test and 6-minute walk distance. Secondary measures included the Functional Independence MeasureTM locomotion score, Fugl-Meyer Lower Extremity Motor Score (FM-LE), Barthel Index, and Stroke Impact Scale. Blinded assessors tested the participants at baseline, post-intervention, and 3-month follow-up. Results: Eleven Lokomat® and nine OGT participants completed the study. Within group differences in the FM-LE score and Barthel Index occurred over time from baseline to post-intervention and baseline to 3-month follow-up. No other within group differences and no between group differences were observed. Conclusions: Although walking measures did not show significant changes between groups, LE motor function and physical functional levels improved over time within both groups. The Lokomat® may allow aggressive locomotor training, particularly for the lower functioning patients who wish to improve walking ability due to apparent eased therapist physical burden, when compared to OGT, although an increased risk of skin breakdown is present. Implications for Rehabilitation Survivors of chronic stroke can continue to improve in motor recovery and functional ability after intensive over-ground or robotic-assisted locomotor training. Over-ground and robotic-assisted locomotor training appear to equivalently enhance motor recovery and functional ability in low functioning survivors of chronic stroke. Risk of skin breakdown is significant with roboticassisted locomotor training.

[1]  C. Granger,et al.  The functional independence measure: a new tool for rehabilitation. , 1987, Advances in clinical rehabilitation.

[2]  C. Anderson,et al.  A population-based assessment of the impact and burden of caregiving for long-term stroke survivors. , 1995, Stroke.

[3]  R. D. de Bie,et al.  Test–re-test reliability of walking speed, step length and step width measurement after traumatic brain injury: a pilot study , 2004, Brain injury.

[4]  Energy cost of machine assisted walking in hemiplegic patients: Preliminary data , 2009 .

[5]  I. Schwartz,et al.  The Effectiveness of Locomotor Therapy Using Robotic‐Assisted Gait Training in Subacute Stroke Patients: A Randomized Controlled Trial , 2009, PM & R : the journal of injury, function, and rehabilitation.

[6]  R. Greenwood,et al.  Use of the Barthel Index and the Functional Independence Measure during early inpatient rehabilitation after single incident brain injury , 2006, Clinical rehabilitation.

[7]  Leslie G. Portney Dpt PhD Fapta,et al.  Foundations of Clinical Research: Applications to Practice , 2015 .

[8]  Bruce H Dobkin,et al.  Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial , 2007, BMC neurology.

[9]  Kari Dunning,et al.  Estimating Clinically Important Change in Gait Speed in People With Stroke Undergoing Outpatient Rehabilitation , 2011, Journal of neurologic physical therapy : JNPT.

[10]  S. Hesse,et al.  Treadmill Training With Partial Body Weight Support and an Electromechanical Gait Trainer for Restoration of Gait in Subacute Stroke Patients: A Randomized Crossover Study , 2002, Stroke.

[11]  Shawn Baker,et al.  Locomotor treadmill training with partial body-weight support before overground gait in adults with acute stroke: a pilot study. , 2008, Archives of physical medicine and rehabilitation.

[12]  F. Müller,et al.  Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Stroke: A Randomized Controlled Pilot Study , 2007, Stroke.

[13]  A. Woodcock,et al.  Two-, six-, and 12-minute walking tests in respiratory disease. , 1982, British medical journal.

[14]  T. Demott,et al.  Enhanced Gait-Related Improvements After Therapist- Versus Robotic-Assisted Locomotor Training in Subjects With Chronic Stroke: A Randomized Controlled Study , 2008, Stroke.

[15]  Pamela W. Duncan,et al.  Similar Motor Recovery of Upper and Lower Extremities After Stroke , 1994, Stroke.

[16]  James M. Wakeling,et al.  Patterns of muscle coordination vary with stride frequency during weight assisted treadmill walking. , 2010, Gait & posture.

[17]  Candy Tefertiller,et al.  Translating Research Into Clinical Practice: Integrating Robotics Into Neurorehabilitation for Stroke Survivors , 2010, Topics in stroke rehabilitation.

[18]  Louise Ada,et al.  Mechanically assisted walking with body weight support results in more independent walking than assisted overground walking in non-ambulatory patients early after stroke: a systematic review. , 2010, Journal of physiotherapy.

[19]  Cynthia D. Brown,et al.  Minimal Clinically Important Differences in the Six-Minute Walk Test and the Incremental Shuttle Walking Test , 2005, COPD.

[20]  S. Sahn,et al.  Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. , 2011, American journal of respiratory and critical care medicine.

[21]  Julie Bernhardt,et al.  Balance and mobility outcomes for stroke patients: a comprehensive audit. , 1997, The Australian journal of physiotherapy.

[22]  Subashan Perera,et al.  Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. , 2003, Archives of physical medicine and rehabilitation.

[23]  L. Connell,et al.  The psychometric properties and clinical utility of measures of walking and mobility in neurological conditions: a systematic review , 2009, Clinical rehabilitation.

[24]  Dallas Johnson,et al.  Conceptualization of a New Stroke-Specific Outcome Measure: The Stroke Impact Scale , 2001, Topics in stroke rehabilitation.

[25]  B. Celli,et al.  The 6-min walk distance in healthy subjects: reference standards from seven countries , 2010, European Respiratory Journal.

[26]  R R Neptune,et al.  Relationships between muscle contributions to walking subtasks and functional walking status in persons with post-stroke hemiparesis. , 2011, Clinical biomechanics.

[27]  S. Embretson,et al.  The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. , 1999, Stroke.

[28]  J. Casillas,et al.  DETERMINING THE MINIMAL CLINICALLY IMPORTANT 1 DIFFERENCE FOR THE SIX-MINUTE WALK TEST AND THE 2002 METER FAST WALK TEST DURING CARDIAC REHABILITATION 3 PROGRAM IN CORONARY ARTERY DISEASE PATIENTS AFTER 4 ACUTE CORONARY SYNDROME , 2017 .

[29]  A. Fugl-Meyer,et al.  The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. , 1975, Scandinavian journal of rehabilitation medicine.

[30]  R. D'Agostino,et al.  The influence of gender and age on disability following ischemic stroke: the Framingham study. , 2003, Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association.

[31]  C. Granger,et al.  Outcome of comprehensive medical rehabilitation: measurement by PULSES profile and the Barthel Index. , 1979, Archives of physical medicine and rehabilitation.

[32]  A. Mayr,et al.  Prospective, Blinded, Randomized Crossover Study of Gait Rehabilitation in Stroke Patients Using the Lokomat Gait Orthosis , 2007, Neurorehabilitation and neural repair.

[33]  R. Riener,et al.  Human-centered robotics applied to gait training and assessment. , 2006, Journal of rehabilitation research and development.

[34]  D. Jette,et al.  Decision-Making Ability of Physical Therapists: Physical Therapy Intervention or Medical Referral , 2006, Physical Therapy.

[35]  J. Mehrholz,et al.  Improved walking ability and reduced therapeutic stress with an electromechanical gait device. , 2009, Journal of rehabilitation medicine.

[36]  F. Mahoney,et al.  FUNCTIONAL EVALUATION: THE BARTHEL INDEX. , 2018, Maryland state medical journal.

[37]  G. Davis,et al.  Cardiorespiratory fitness and walking ability in subacute stroke patients. , 2003, Archives of physical medicine and rehabilitation.

[38]  S. Hesse,et al.  Muscle coordination in healthy subjects during floor walking and stair climbing in robot assisted gait training , 2008, 2008 30th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[39]  A. Porta,et al.  Effects of robot-driven gait orthosis treadmill training on the autonomic response in rehabilitation-responsive stroke and cervical spondylotic myelopathy patients. , 2010, Gait & posture.

[40]  Orit Shechtman,et al.  Foundations of Clinical Research: Applications to Practice, 2nd Edition, Leslie Gross Portney, Mary P. Watkins. Prentice Hall, Upper Saddle River, NJ (2000), 752 pages. $60 , 2001 .

[41]  A. Jette Toward a common language for function, disability, and health. , 2006, Physical therapy.

[42]  Catherine E Lang,et al.  Counting Repetitions: An Observational Study of Outpatient Therapy for People with Hemiparesis Post-Stroke , 2007, Journal of neurologic physical therapy : JNPT.

[43]  JoAnne K. Gronley,et al.  Classification of walking handicap in the stroke population. , 1995, Stroke.

[44]  B. Knowlton,et al.  Step training with body weight support: effect of treadmill speed and practice paradigms on poststroke locomotor recovery. , 2002, Archives of physical medicine and rehabilitation.

[45]  G. Fulk,et al.  Clinometric properties of the six-minute walk test in individuals undergoing rehabilitation poststroke , 2008, Physiotherapy theory and practice.

[46]  S. Studenski,et al.  Predicting Stroke Recovery: Three and Six‐Month Rates of Patient‐Centered Functional Outcomes Based on the Orpington Prognostic Scale , 2001, Journal of the American Geriatrics Society.

[47]  Carmen Krewer,et al.  The influence of different Lokomat walking conditions on the energy expenditure of hemiparetic patients and healthy subjects. , 2007, Gait & posture.

[48]  V. Dietz,et al.  Treadmill training of paraplegic patients using a robotic orthosis. , 2000, Journal of rehabilitation research and development.

[49]  Kelly P Westlake,et al.  Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke , 2009, Journal of NeuroEngineering and Rehabilitation.

[50]  S. Harkema,et al.  Locomotor training after human spinal cord injury: a series of case studies. , 2000, Physical therapy.

[51]  E. Roth,et al.  Locomotor Training Improves Daily Stepping Activity and Gait Efficiency in Individuals Poststroke Who Have Reached a “Plateau” in Recovery , 2010, Stroke.

[52]  S Hesse,et al.  Treadmill walking with partial body weight support versus floor walking in hemiparetic subjects. , 1999, Archives of physical medicine and rehabilitation.

[53]  V. Dietz,et al.  Biofeedback in gait training with the robotic orthosis Lokomat , 2004, The 26th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[54]  Bruce H Dobkin,et al.  Body-weight-supported treadmill rehabilitation after stroke. , 2011, The New England journal of medicine.

[55]  J. Whitall,et al.  Cardiovascular risk in survivors of stroke. , 2007, American journal of preventive medicine.

[56]  Steven Y Cen,et al.  Meaningful Gait Speed Improvement During the First 60 Days Poststroke: Minimal Clinically Important Difference , 2010, Physical Therapy.

[57]  S J Jay,et al.  Reference equations for the six-minute walk in healthy adults. , 2000 .

[58]  Dina Brooks,et al.  Use of the six-minute walk test poststroke: is there a practice effect? , 2008, Archives of physical medicine and rehabilitation.