title: Safety and efficacy of at-home robotic locomotion therapy in individuals with chronic incomplete spinal cord injury: a prospective, pre-post intervention, proof-of-concept study.
abstract: BACKGROUND
  The compact Motorized orthosis for home rehabilitation of Gait (MoreGait) was developed for continuation of locomotion training at home. MoreGait generates afferent stimuli of walking with the user in a semi-supine position and provides feedback about deviations from the reference walking pattern.
  
  
  OBJECTIVE
  Prospective, pre-post intervention, proof-of-concept study to test the feasibility of an unsupervised home-based application of five MoreGait prototypes in subjects with incomplete spinal cord injury (iSCI).
  
  
  METHODS
  Twenty-five (5 tetraplegia, 20 paraplegia) participants with chronic (mean time since injury: 5.8 ± 5.4 (standard deviation, SD) years) sensorimotor iSCI (7 ASIA Impairment Scale (AIS) C, 18 AIS D; Walking Index for Spinal Cord Injury (WISCI II): Interquartile range 9 to 16) completed the training (45 minutes / day, at least 4 days / week, 8 weeks). Baseline status was documented 4 and 2 weeks before and at training onset. Training effects were assessed after 4 and 8 weeks of therapy.
  
  
  RESULTS
  After therapy, 9 of 25 study participants improved with respect to the dependency on walking aids assessed by the WISCI II. For all individuals, the short-distance walking velocity measured by the 10-Meter Walk Test showed significant improvements compared to baseline (100%) for both self-selected (Mean 139.4% ± 35.5% (SD)) and maximum (Mean 143.1% ± 40.6% (SD)) speed conditions as well as the endurance estimated with the six-minute walk test (Mean 166.6% ± 72.1% (SD)). One device-related adverse event (pressure sore on the big toe) occurred in over 800 training sessions.
  
  
  CONCLUSIONS
  Home-based robotic locomotion training with MoreGait is feasible and safe. The magnitude of functional improvements achieved by MoreGait in individuals with iSCI is well within the range of complex locomotion robots used in hospitals. Thus, unsupervised MoreGait training potentially represents an option to prolong effective training aiming at recovery of locomotor function beyond in-patient rehabilitation.
  
  
  BACKGROUND
  German Clinical Trials Register (DKRS) DRKS00005587.
authors: Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany.
authors: Rüdiger
authors: R
authors: Rupp
authors: Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany.
authors: Daniel
authors: D
authors: Schließmann
authors: Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany.
authors: Harry
authors: H
authors: Plewa
authors: Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany.
authors: Christian
authors: C
authors: Schuld
authors: Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany.
authors: Hans Jürgen
authors: HJ
authors: Gerner
authors: Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany.
authors: Norbert
authors: N
authors: Weidner
authors: Ulm University, Institute of Measurement, Control and Microtechnology, Ulm, Germany.
authors: Eberhard P
authors: EP
authors: Hofer
authors: Ulm University, Institute of Measurement, Control and Microtechnology, Ulm, Germany.
authors: Markus
authors: M
authors: Knestel
mesh_terms: D000328:Adult; D005081:Exercise Therapy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D005260:Female; D020233:Gait Disorders, Neurologic / Q000503:physiopathology / Q000534:rehabilitation; D006699:Home Care Services; D006801:Humans; D008124:Locomotion; D008297:Male; D008875:Middle Aged; D010264:Paraplegia / Q000503:physiopathology / Q000534:rehabilitation; D011446:Prospective Studies; D011782:Quadriplegia / Q000503:physiopathology / Q000534:rehabilitation; D020127:Recovery of Function; D012371:Robotics / Q000295:instrumentation*; D013119:Spinal Cord Injuries / Q000503:physiopathology / Q000534:rehabilitation*