Background: A novel electromechanical robotic-exoskeleton was designed in-house for the rehabilitation of wrist joint and Metacarpophalangeal (MCP) joint. Objective: The objective was to compare the rehabilitation effectiveness (clinical-scales and neurophysiological-measures) of robotic-therapy training sessions with dose-matched conventional therapy in patients with stroke. Methods: A pilot prospective parallel randomized controlled study at clinical settings was designed for patients with stroke within 2 years of chronicity. Patients were randomly assigned to receive an intervention of 20 sessions of 45 min each, five days a week for four weeks, in Robotic-therapy Group (RG) (n = 12) and conventional upper-limb rehabilitation in Control-Group (CG) (n = 11). We intended to evaluate the effects of a novel exoskeleton based therapy on the functional rehabilitation outcomes of upper-limb and cortical-excitability in patients with stroke as compared to the conventional-rehabilitation. Clinical-scales– Modified Ashworth Scale, Active Range of Motion, Barthel-Index, Brunnstrom-stage and Fugl-Meyer (FM) scale and neurophysiological measures of cortical-excitability (using Transcranial Magnetic Stimulation) –Motor Evoked Potential and Resting Motor threshold, were acquired pre- and post-therapy. Results: No side effects were noticed in any of the patients. Both RG and CG showed significant (p < 0.05) improvement in all clinical motor-outcomes except Modified Ashworth Scale in CG. RG showed significantly (p < 0.05) higher improvement over CG in Modified Ashworth Scale, Active Range of Motion and Fugl-Meyer scale and FM Wrist-/Hand component. An increase in cortical-excitability in ipsilesional-hemisphere was found to be statistically significant (p < 0.05) in RG over CG, as indexed by a decrease in Resting Motor Threshold and increase in the amplitude of Motor Evoked Potential. No significant changes were shown by the contralesional-hemisphere. Interhemispheric RMT-asymmetry evidenced significant (p < 0.05) changes in RG over CG indicating increased cortical-excitability in ipsilesional-hemisphere along with interhemispheric changes. Conclusion: Robotic-exoskeleton training showed improvement in motor outcomes and cortical-excitability in patients with stroke. Neurophysiological changes in RG could most likely be a consequence of plastic reorganization and use-dependent plasticity. Trial registry number: ISRCTN95291802

Robots have the potential to help provide exercise therapy in a repeatable and reproducible manner for stroke survivors. To facilitate rehabilitation of the wrist and fingers joint, an electromechanical exoskeleton was developed that simultaneously moves the wrist and metacarpophalangeal joints. The device was designed for the ease of manufacturing and maintenance, with specific considerations for countries with limited resources. Active participation of the user is ensured by the implementation of electromyographic control and visual feedback of performance. Muscle activity requirements, movement parameters, range of motion and speed, of the device can all be customized to meet the needs of the user. Twelve stroke survivors, ranging from the subacute to chronic phases of recovery (mean 10.6 months post-stroke) participated in a pilot study with the device. Participants completed 20 sessions, each lasting 45 minutes. Overall, subjects exhibited statistically significant changes (p 0.05) in clinical outcome measures following the treatment, with the Fugl-Meyer Stroke Assessment score for the upper extremity increasing from 36 to 50 and the Barthel Index increasing from 74 to 89. Active range of wrist motion increased by 19 while spasticity decreased from 1.75 to 1.29 on the Modified Ashworth Scale. Thus, this device shows promise for improving rehabilitation outcomes, especially for patients in countries with limited resources.