A pilot randomized controlled trial of robotic exoskeleton-assisted exercise rehabilitation in multiple sclerosis

Abstract

Background: Co-occurring mobility and cognitive impairments are common, debilitating, and poorly-managed with pharmacological therapies in persons with multiple sclerosis (MS). Exercise rehabilitation (ER), particularly walking ER, has been suggested as one of the best approaches for managing these manifestations of MS. However, there is a focal lack of efficacy of ER on mobility and cognitive outcomes in persons with MS who present with substantial neurological disability. Such severe neurological disability oftentimes precludes the ability for participation in highly-intensive and repetitive ER that is necessary for eliciting adaptations in mobility and cognition. To address such a concern, robotic exoskeleton-assisted ER (REAER) might represent a promising intervention approach for managing co-occurring mobility and cognitive impairments in those with substantial MS disability who might not benefit from traditional ER. Methods: The current pilot single-blind, randomized controlled trial (RCT) compared the effects of 4-weeks of REAER with 4-weeks of conventional gait training (CGT) as a standard-of-care control condition on functional mobility (timed up-and-go; TUG), walking endurance (six-minute walk test; 6MWT), cognitive processing speed (CPS; Symbol Digit Modalities Test; SDMT), and brain connectivity (thalamocortical resting-state functional connectivity (RSFC) based on fMRI) outcomes in 10 persons with substantial MS-related neurological disability. Results: Overall, compared with CGT, 4-weeks of REAER was associated with large improvements in functional mobility (η p 2 =.38), CPS (η p 2 =.53), and RSFC between the thalamus and ventromedial prefrontal cortex (η p 2 =.72),but not walking endurance (η p 2 =.01). Further, changes in RSFC were moderately associated with changes in TUG, 6MWT, and SDMT performance, respectively, whereby increased thalamocortical RSFC was associated with improved functional mobility, walking endurance, and CPS (|ρ|>.36). Conclusion:The current pilot RCT provides initial support for REAER as an approach for improving functional mobility and CPS, perhaps based on adaptive and integrative central nervous system plasticity, namely increases in RSFC between the thalamus and ventromedial prefrontal cortex, in a small sample of persons with substantial MS disability. Such a pilot trial provides proof-of-concept data for the design and implementation of an appropriately-powered RCT of REAER in a larger sample of persons with MS who present with co-occurring impairments in both mobility and cognitive functioning.

Use of Robotic Devices for Gait Training in Patients Diagnosed with Multiple Sclerosis: Current State of the Art

“…Seventeen RCTs [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 ] (537 participants) were included. All articles were published in English.…”

“…Nine of the studies [ 23 , 24 , 25 , 27 , 28 , 29 , 30 , 33 , 34 ] included two comparison groups: the experimental group, the group where the intervention to be evaluated was performed, and the control group, the group with which the results were compared, and a conservative treatment was applied. The remaining studies were pre–post studies or comparisons between two types of interventions (comparative studies) [ 26 , 31 , 34 , 35 , 36 , 37 , 38 , 39 ].…”

“…At the motor level, the following measures were used: the timed get-up-and-go (TGUG) [ 23 , 24 , 30 , 32 , 34 , 35 , 36 ], Tinetti [ 23 , 25 , 31 ], 25-foot walking test [ 25 , 29 , 33 , 34 , 37 ], six-minute walking test [ 25 , 27 , 29 , 30 , 32 , 34 , 35 ], Modified Motricity Index for Lower Limbs [ 25 ], gait parameters such as cadence and speed [ 25 , 29 , 32 , 37 , 39 ], the two-minutes walking test [ 28 , 39 ], Functional Ambulatory Category [ 26 ], Barthel [ 28 ], Rivermead Mobility Index [ 28 ], and the 10-step stair test [ 27 , 31 ].…”

“…The following scales were used for cognitive assessment: the Hamilton Rating Scale for Depression (HRSD) [ 23 , 24 , 27 ], the Coping Orientation to Problem Experience (COPE) [ 24 ], the MSIS-29 [ 29 ], mental quickness, and brain connectivity [ 27 , 30 , 38 ].…”

Comparative Assessment of Robotic versus Classical Physical Therapy Using Muscle Strength and Ranges of Motion Testing in Neurological Diseases

“…The efficacity of robotic physical therapy was also tested in [ 6 , 7 , 8 , 9 ], with similar results: robotic physical therapy was as effective as conventional physical therapy.…”