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.

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.

Electric impedance tomography for monitoring volume and size of the urinary bladder.

A novel non-invasive technique for monitoring fluid content in the human bladder is described. Specifically, a precommercial electric impedance tomograph (EIT) was applied to measure and visualize impedance changes in the lower torso due to changes in bladder volume. Preliminary measurements were conducted during routine urodynamic tests of nine male paraplegic patients, in whom a contrast agent was slowly infused into the bladder for diagnostic purposes. In some patients, a good correlation between bladder volume and EIT measurements was found, whereas in others the correlation was still good but inverted, presumably due to a poor electrode positioning. These preliminary results indicate that a sufficiently accurate finite element modeling of the impedance distribution in the abdomen, and proper electrode positioning aids, are important prerequisites to enable this technology to be used for routine measurement of bladder volume.

MotionTherapy@Home - First results of a clinical study with a novel robotic device for automated locomotion therapy at home.

In incomplete spinal cord injured subjects, task-oriented training regimes are applied for enhancement of neuroplasticity to improve gait capacity. However, a sufficient training intensity can only be achieved during the inpatient phase, which is getting shorter and shorter due to economic restrictions. In the clinical environment, complex and expensive robotic devices have been introduced to maintain the duration and the intensity of the training, but up to now only a few exist for continuation of automated locomotion training at home. For continuation of the automated locomotion training at home prototypes of the compact, pneumatically driven orthosis MoreGait have been realized, which generate the key afferent stimuli for activation of the spinal gait pattern generator. Artificial pneumatic muscles with excellent weight-to-force ratio and safety characteristics have been integrated as joint actuators. Additionally, a Stimulative Shoe for generation of the appropriate foot loading pattern has been developed without the need for verticalization of the user. The first results of the pilot study in eight chronic incomplete spinal cord injured subjects indicate that the home-based therapy is safe and feasible. The therapy related improvements of the walking capacity are in the range of locomotion robots used in clinical settings.