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Evaluation of the Keeogo exoskeleton for assisting ambulatory activities in people with multiple sclerosis: an open-label, randomized, cross-over trial
McGibbon CA, Sexton A, Jayaraman A, Deems-Dluhy S, Gryfe P, Novak A, Dutta T, Fabara E, Adans-Dester C, Bonato P
Journal of NeuroEngineering & Rehabilitation 2018 Dec 12;15(117):Epub
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Although physical activity and exercise is known to benefit people with multiple sclerosis (MS), the ability of these individuals to participate in such interventions is difficult due to the mobility impairments caused by the disease. Keeogo is a lower-extremity powered exoskeleton that may be a potential solution for enabling people with MS to benefit from physical activity and exercise. METHODS: An open-label, randomized, cross-over trial was used to examine the immediate performance effects when using the device, and the potential benefits of using the device in a home setting for 2 weeks. Clinical performance tests with and without the device included the 6 min walk test, timed up and go test and the 10-step stair test (up and down). An activity monitor was also used to measure physical activity at home, and a patient-reported questionnaire was used to determine the amount and extent of home use. Generalized linear models were used to test for trial effects, and correlation analysis used to examine relationships between trial effects and usage. RESULTS: Twenty-nine patients with MS participated. All measures showed small decrements in performance while wearing the device compared to not wearing the device. However, significant improvements in unassisted (Rehab effect) performance were found after using the device at home for 2 weeks, compared to 2 weeks at home without the device, and participants improved their ability to use the device over the trial period (Training effect). Rehab and Training effects were related to the self-reported extent that participants used Keeogo at home. CONCLUSIONS: Keeogo appears to deliver an exercise-mediated benefit to individuals with MS that improved their unassisted gait endurance and stair climbing ability. Keeogo might be a useful tool for delivering physical activity interventions to individuals with mobility impairment due to MS. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02904382. Registered 19 September 2016 -- retrospectively registered.

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