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

PLoS One. 2015 Mar 24;10(3):e0119167. doi: 10.1371/journal.pone.0119167. eCollection 2015.

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.

Trial registration: German Clinical Trials Register (DKRS) DRKS00005587.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Exercise Therapy / adverse effects
  • Exercise Therapy / instrumentation*
  • Exercise Therapy / methods
  • Female
  • Gait Disorders, Neurologic / physiopathology
  • Gait Disorders, Neurologic / rehabilitation
  • Home Care Services*
  • Humans
  • Locomotion
  • Male
  • Middle Aged
  • Paraplegia / physiopathology
  • Paraplegia / rehabilitation
  • Prospective Studies
  • Quadriplegia / physiopathology
  • Quadriplegia / rehabilitation
  • Recovery of Function
  • Robotics / instrumentation*
  • Spinal Cord Injuries / physiopathology
  • Spinal Cord Injuries / rehabilitation*

Associated data

  • DRKS/DRKS00005587

Grants and funding

This project was supported by the German Federal Ministry of Education and Research (BMBF, www.bmbf.de) under grant no. 01EZ601 and 01EZ0602 from 2006-2010 and from 2011-2014 by the German Federal Ministry of Economic affairs and Energy (BMWi, www.bmwi.de) on the basis of a decision by the German Bundestag under grant no. KF2906701. Additionally, financial support was received by the Deutsche Forschungsgemeinschaft and Ruprecht-Karls-University Heidelberg within the funding program "Open Access Publishing". The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.