Effectiveness of a Powered Exoskeleton Combined With Functional Electric Stimulation for Patients With Chronic Spinal Cord Injury: a Randomized Controlled Trial

Brief Summary

Detailed Description

Paraplegia is a serious event that leads to a complete or partial loss of motor, sensory and vegetative functions. Regaining of gait, balance and mobility are important priorities for persons with a spinal cord injury (SCI). In the last decade the technological development of exoskeletons allowed persons with SCI getting closer to their desired goal. Wearable robotic exoskeletons are motorized orthoses that facilitate untethered standing and walking over ground. Supporting multiple step repetitions while having full weight bearing on the body, these devices represent a task-specific and -oriented training approach for rehabilitation of gait function after SCI. However, in cases where rehabilitation of gait function is not the aim, the need to target secondary health problems associated with SCI like pain, spasticity, bowel and bladder function can still be a rationale for engaging in exoskeleton training. Another well-established technique for the treatment of such secondary health problems is functional electrical stimulation (FES). FES is a common and established method for the rehabilitation of persons with spinal cord injury. Several studies have documented positive effects of FES like, e.g., avoiding disuse and denervation atrophy, improving muscle force, power output and endurance, changing muscle fibre type, increasing cross sectional area of muscles, increasing muscle mass, activation of nerve sprouting, motor learning and reducing spasticity. In addition, FES has been shown to improve bladder, bowel and sexual function, cardiovascular fitness (by increasing aerobic capacity), reduce body fat mass and prevent and treat pressure ulcers by increasing muscular blood flow. Moreover, FES treatment has also been shown to have an impact on body function by improving lower limb function as well as trunk stability and function. The power elicited by the muscle through electrical stimulation can be used for locomotion. To do so, undesired limb motion is often restricted by passive orthoses or pedals in order to efficiently use the muscle contraction from the user to safely provide the power for forward propulsion. The usefulness of such systems, however, is often limited due to the rapid initiation of muscle fatigue. This is one reason (amongst others) why hybrid FES-robotic solutions have been developed, which supplement the power produced by electrical stimulation with motorized assistance. This approach reduces the power that needs to be produced by the muscles, allowing for FES application for longer training sessions before fatigue occurs. By doing so, such hybrid powered exoskeletons offer the physiological health benefits similar to FES cycling, while simultaneously enhancing the user's mobility. The addition of FES to a powered exoskeleton also synergistically reduces the motor torques of the device, reducing battery drain and therefore increasing the maximum range of the exoskeleton. While it sounds perfectly reasonable, from a technical and physiological perspective, to combine powered exoskeletons and FES to such hybrid bionic systems, there is only anecdotal evidence for their clinical usefulness and efficacy in patients with SCI. Here the investigators propose a randomized controlled trial investigating the effect of the combined application of the EksoNR powered exoskeleton (Ekso Bionics, Richmond, CA, USA) and FES (FES RehaMove2, Hasomed, Magdeburg, Germany) compared to Ekso therapy alone on functional outcomes and secondary health parameters.

Primary Outcomes

Secondary Outcomes

• Changes from baseline at Visit 2 and Visit 3 in the standing balance assessment using the zebris pressure distribution measurement platform (zebris Medical GmbH, Isny, Germany)(within 3 days post-training, 3 months post intervention)
• Training duration in the Exoskeleton(week 1 to week 8)
• change from baseline (Visit 1) in preferred walking speed, measured by the 10MWT, at Visit 3(3 months post intervention)
• Training intensity in the Exoskeleton(week 1 to week 8)
• Changes from baseline at Visit 2 and Visit 3 in maximal walking speed measured by the 10MWT(within 3 days post-training, 3 months post intervention)
• Changes from baseline at Visit 2 and Visit 3 in gait function as measured by the Walking Index for Spinal Cord Injury II (WISCI II)(within 3 days post-training, 3 months post intervention)
• Changes from baseline at Visit 2 and Visit 3 in strength using the Medical Research Council Manual Muscle Test (MRC MMT)(within 3 days post-training, 3 months post intervention)
• Changes from baseline at Visit 2 and Visit 3 in Quality of Life will be assessed according to the International SCI Quality of Life Basic Data Set(within 3 days post-training, 3 months post intervention)
• Training volume in the Exoskeleton(week 1 to week 8)
• Cardio-respiratory measurement(week 2, week 8)
• Changes from baseline at Visit 2 and Visit 3 in endurance as measured by the 6 Minute Walk Test (6mWT)(within 3 days post-training, 3 months post intervention)
• Changes from baseline at Visit 2 and Visit 3 in balance function as measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)(within 3 days post-training, 3 months post intervention)