Safety and usability of the MAK exoskeleton in patients with stroke

Abstract

Background and purposeStroke is one of the leading causes of disability in adults worldwide, and one of the main objectives in the rehabilitation of these patients is to recover the gait. New technologies have emerged to cope with this issue, complementing conventional therapy with the use of devices such as exoskeletons. The Marsi Active Knee (MAK) exoskeleton (Marsi Bionics SL, Madrid, Spain) has already been tested, but an updated version was improved to allow the patients to perform functional exercises. The aim of this study was to assess the safety and usability of the MAK in the stroke population as well as its potential clinical effects.MethodsA single‐group open label intervention trial was conducted. The device was used twice a week for 5 weeks during 1 h per visit. During the visits, sit‐to‐stand transitions, walking, stair climbing, trunk rotations, and weight‐transfer exercises were performed using the device. Adverse events were collected from participants and therapists to assess safety. The Quebec User Evaluation of the Satisfaction with assistive Technology (QUEST 2.0) was used by both therapists and participants to assess usability. To evaluate its clinical effects, active range of motion (ROM) and muscle strength were assessed in the lower limb.ResultsSix participants with stroke were recruited. The device was shown to be safe since no serious adverse events were reported neither by patients nor by therapists. Every proposed exercise was performed. Regarding clinical effects, overall muscle strength showed an increase after the treatment, although ROM measurements did not show any difference.DiscussionOur results suggest that the MAK device is safe for stroke patients. Nevertheless, further changes to enhance usability are recommended, such as an improvement of the attachment system and an adaptation for the drop foot. Beneficial effects regarding increases in muscle strength were obtained. Further trials with a larger sample size, longer intervention periods, and a control group are needed to verify these results. Also, future research should focus on the usability of the MAK as an assistive technology.

STELO: A New Modular Robotic Gait Device for Acquired Brain Injury—Exploring Its Usability

“…Regarding robotic devices that assist a single joint, the ankle robotic system ReStore (ReWalk Robotics, Inc., Marlborough, MA, USA) obtained a normalized score of 84.5% in the QUEST 2.0 after eight sessions [ 43 ], significantly higher than the perceived satisfaction with the T-FLEX, which obtained a score of 33.3% after one session [ 44 ]. The knee robotic device MAK (Marsi Bionics SL, Madrid, Spain) obtained a normalized score of 56% after three sessions [ 23 ] and 66.5% after nine sessions [ 22 ], while the knee robotic system ALLOR obtained a score of 84.0% after a single session [ 45 ].…”

“…On the other hand, the exoskeleton modules have been designed using the modular technology of the Marsi active knee (MAK) device [ 22 , 23 ], already certified as electro-medical equipment. Nevertheless, some adaptations regarding the electric motors and gears have been created to provide sufficient power to assist flexion and extension movements during walking, sitting, and standing at each joint.…”

Modularity Implications of an Overground Exoskeleton on Plantar Pressures, Strength, and Spasticity in Persons with Acquired Brain Injury

“…Additionally, the system detects the force and resistance exerted by the user, which is crucial for control algorithms based on movement intention detection, and provides assistance accordingly. The modular design of the exoskeleton draws inspiration from the Marsi Active Knee (MAK, Marsi Bionics SL, Madrid, Spain) device [ 23 ], a certified piece of electro-medical equipment. Adaptations to electric motors and gears were made to provide ample power for assisting flexion and extension movements during various activities.…”

Prototyping of Remote-Controlled Robotic Hand Based on Flex Sensor, a Preliminary Research for the Development of Post-Stroke Therapy Assistive Device

“…In 2013, collaboration between researcher from Germany, Austria, Italy, and Swiss resulted an assistive device named MUNDUS (Multimodal Neuro-prosthesis for daily Upper limb Support). MUNDUS was developed in order to assist the rehabilitation process for several basic movement in daily activities [6]The research of post-stroke assistive therapy devices still continues and become more specified in several body parts like ExStRA [7], REFLEX [8], RobHand [9], RAGT [10], Marsi Active Knee (MAK) [11], ExoAtlet [12] Robotic Exoskeleton (REs) [13], Harmony [14] and many more. These previous researches indicated about the seriousness of international community about the development of post-stroke assistive device in order to improve the recovery process.…”