An integrated COgnitive-somatoSensory-MOtor training intervention for upper limb recovery after stroke: Protocol for a Phase II randomized controlled trial

Background: Up to 85% of stroke survivors experience motor, somatosensory and cognitive deficits. Interventions that simultaneously stimulate motor, somatosensory and cognitive functions have the potential to maximize processes of neuroplasticity and optimise upper limb recovery after stroke. This study aims to investigate the feasibility of a personalised integrated COgnitive-somatoSensory-MOtor (iCOSMO) training intervention to improve upper limb recovery in people with chronic stroke. The objectives are: 1) to evaluate the feasibility, and 2) to determine the preliminary efficacy of the iCOSMO intervention in people with chronic stroke. Methods: The study design will be a prospective pilot randomised controlled trial with two-arms. We aim to recruit 40 adults with stroke (>6 months). The iCOSMO intervention will consist of a combination of haptic perception exploratory tasks that incorporate active touch and movement exploratory procedures, robotic training using the Kinarm Exoskeleton device, with a cognitive focus on the motor and sensory attributes of all of the tasks. iCOSMO will be goal-oriented and individualised to the nature and severity of upper limb somatosensory and motor deficits. The experimental group will receive a total of 36 hours of treatment over 6 weeks. The control group will receive a matched dose of a Graded Repetitive Arm Supplementary Program home-based motor exercise programme. Feasibility measures will evaluate the recruitment and adherence rates. Robotic assessments will be conducted using the Kinarm standard tasks™. Standardised clinical assessments will include the Action Research Motor Test and the Tactile Discrimination Test. Conclusion: This study will be the first to demonstrate whether it is both feasible and beneficial to deliver a personalised intervention integrating somatosensory, motor and cognitive training in one protocol. The iCOSMO study may also show that it is feasible to individualise the intervention tasks to the nature and severity of upper limb deficits. It is also expected that the iCOSMO training intervention will improve the arm and hand function to a larger extent than the GRASP training in chronic stroke survivors. This proposed study will help better understand the impact of combining cognitive, somatosensory, and motor training in task performance. Trial registration: This trial was prospectively registered on Clinicaltrial.gov (NCT06498011) on July, 12th, 2024 and is available at https://clinicaltrials.gov/study/NCT06498011