Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI (RVZU)

Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury

The aim of the project is to test the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. In a randomised controlled two-arm trial, the effect of adding two types of robot-assisted upper-limb exercise to standard occupational therapy will be tested. Three primary and two secondary outcomes will be assessed using well-established measures.

Unlike for persons after stroke, there is no high-quality evidence of the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. For this reason, we are aiming to conduct a randomised trial. The trial will involve two groups of adult patients admitted to inpatient rehabilitation. One group will receive standard occupational therapy, tailored to the patient's needs and abilities, five times per week for 90 minutes. In addition to the standard occupational therapy, the other group will receive ten 30-minute session of robot-assisted exercise: five sessions of exercise for fingers and hand using a specialised device, and five sessions of gross-motor exercise using an exoskeleton. Four outcome measures will be used to comprehensively assess the patients at the beginning and at the end of the intervention, i.e., upon admission and discharge: the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP; general and Myelopathy version), the American Spinal Injury Association Impairment Scale (ASIA), the Spinal Cord Independence Measure (SCIM), and the Canadian Occupational Performance Measure (COPM). The progress in those measures will be compared between the two groups.

Standard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities) + five 30' sessions (2-3 per week) of robot-assisted exercise for fingers and hand using Amadeo device + five 30' sessions (2-3 per week) of robot-assisted exercise using Armeo Spring exoskeleton for facilitating gross movements of upper limbs

Standard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities)

Exercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton

Clinical impairment measure specific to the upper limb for use after tetraplegia that measures sensorimotor and prehension function through three domains; higher scores mean a better outcome

Difference in Graded Redefined Assessment of Strength, Sensibility and Prehension - Mielopathy (GRASSP-M) score

Objective tool designed to characterize patients' functional impairment related to the upper limb, useful for diagnosing and quantifying mild dysfunction and monitoring patients for deterioration; higher scores mean a better outcome

Standardised physical examination consisting of myotomal-based motor examination, dermatomal-based sensory examination, and anorectal examination; upon completion of these three components, an injury grade and level are assigned; higher scores mean a better outcome

Assessement of performance in activities of daily living and mobility for individuals with spinal cord injury; higher scores mean a better outcome

Individualized, client-centred outcome measure designed to capture a client's self-perception of performance in everyday living, over time; higher performance and satisfaction scores mean a better outcome

Inclusion Criteria: ability to move unloaded upper limbs at least 18 years of age ability to sit for one hour ability to understand the instructions for robot-assisted exercise Exclusion Criteria: inability to sit for one hour presence of hospital-acquired infection that requires isolation bodily impairment other than spinal cord injury inability to understand the instructions for robot-assisted exercise