Browsing by Author "Fitle, Kyle"
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Item Design of a parallel-group balanced controlled trial to test the effects of assist-as-needed robotic therapy(IEEE, 2015) Sergi, Fabrizio; Pehlivan, Ali Utku; Fitle, Kyle; Nedley, Kathryn; Yozbatiran, Nuray; Francisco, Gerard E.; O’Malley, Marcia K.; Mechatronics and Haptic Interfaces LaboratoryIn this methods paper, we report on the design of a clinical study testing the efficacy of a newly developed control scheme for robot-aided rehabilitation. To measure the value added by a new control scheme, we pursued a parallel-group controlled clinical study design. This approach enables comparing the effects of the novel scheme, based on the Assist-As-Needed (AAN) paradigm, with those of a less sophisticated, fixed gain, Subject-Triggered (ST) controller. We describe the steps followed in the design of this clinical study, including details on the implementation of the two control modes, and a power analysis to determine the required number of subjects to test a clinically significant difference hypothesis. Finally, we present a method for sequential group assignment with co-variates minimization, capable of guaranteeing a desired level of balance of prognostic factors in the two study groups, a crucial requisite for small-scale clinical studies in rehabilitation. To the best of our knowledge, the study presented is the first one testing, in a controlled fashion, the differential effects of a specific control mode in upper extremity rehabilitation after incomplete spinal cord injury.Item Effects of Assist-As-Needed Upper Extremity Robotic Therapy after Incomplete Spinal Cord Injury: A Parallel-Group Controlled Trial(Frontiers Media S.A., 2017) Frullo, John Michael; Elinger, Jared; Pehlivan, Ali Utku; Fitle, Kyle; Nedley, Kathryn; Francisco, Gerard E.; Sergi, Fabrizio; O’Malley, Marcia K.Background: Robotic rehabilitation of the upper limb following neurological injury has been supported through several large clinical studies for individuals with chronic stroke. The application of robotic rehabilitation to the treatment of other neurological injuries is less developed, despite indications that strategies successful for restoration of motor capability following stroke may benefit individuals with incomplete spinal cord injury (SCI) as well. Although recent studies suggest that robot-aided rehabilitation might be beneficial after incomplete SCI, it is still unclear what type of robot-aided intervention contributes to motor recovery. Methods: We developed a novel assist-as-needed (AAN) robotic controller to adjust challenge and robotic assistance continuously during rehabilitation therapy delivered via an upper extremity exoskeleton, the MAHI Exo-II, to train independent elbow and wrist joint movements. We further enrolled seventeen patients with incomplete spinal cord injury (AIS C and D levels) in a parallel-group balanced controlled trial to test the efficacy of the AAN controller, compared to a subject-triggered (ST) controller that does not adjust assistance or challenge levels continuously during therapy. The conducted study is a stage two, development-of-concept pilot study. Results: We validated the AAN controller in its capability of modulating assistance and challenge during therapy via analysis of longitudinal robotic metrics. For the selected primary outcome measure, the pre–post difference in ARAT score, no statistically significant change was measured in either group of subjects. Ancillary analysis of secondary outcome measures obtained via robotic testing indicates gradual improvement in movement quality during the therapy program in both groups, with the AAN controller affording greater increases in movement quality over the ST controller. Conclusion: The present study demonstrates feasibility of subject-adaptive robotic therapy after incomplete spinal cord injury, but does not demonstrate gains in arm function occurring as a result of the robot-assisted rehabilitation program, nor differential gains obtained as a result of the developed AAN controller. Further research is warranted to better quantify the recovery potential provided by AAN control strategies for robotic rehabilitation of the upper limb following incomplete SCI.Item Robot-Assisted Training of Arm and Hand Movement Shows Functional Improvements for Incomplete Cervical Spinal Cord Injury(Wolters Kluwer, 2017) Francisco, Gerard E.; Yozbatiran, Nuray; Berliner, Jeffrey; O'Malley, Marcia K.; Pehlivan, Ali Utku; Kadivar, Zahra; Fitle, Kyle; Boake, CorwinObjective The aim of the study was to demonstrate the feasibility, tolerability, and effectiveness of robotic-assisted arm training in incomplete chronic tetraplegia. Design Pretest/posttest/follow-up was conducted. Ten individuals with chronic cervical spinal cord injury were enrolled. Participants performed single degree-of-freedom exercise of upper limbs at an intensity of 3-hr per session for 3 times a week for 4 wks with MAHI Exo-II. Arm and hand function tests (Jebsen-Taylor Hand Function Test, Action Research Arm Test), strength of upper limb (upper limb motor score, grip, and pinch strength), and independence in daily living activities (Spinal Cord Independence Measure II) were performed at baseline, end of training, and 6 mos later. Results After 12 sessions of training, improvements in arm and hand functions were observed. Jebsen-Taylor Hand Function Test (0.14[0.04]–0.21[0.07] items/sec, P = 0.04), Action Research Arm Test (30.7[3.8]–34.3[4], P = 0.02), American Spinal Injury Association upper limb motor score (31.5[2.3]–34[2.3], P = 0.04) grip (9.7[3.8]–12[4.3] lb, P = 0.02), and pinch strength (4.5[1.1]–5.7[1.2] lb, P = 0.01) resulted in significant increases. Some gains were maintained at 6 mos. No change in Spinal Cord Independence Measure II scores and no adverse events were observed. Conclusions Results from this pilot study suggest that repetitive training of arm movements with MAHI Exo-II exoskeleton is safe and has potential to be an adjunct treatment modality in rehabilitation of persons with spinal cord injury with mild to moderate impaired arm functions.