The Effect of Robot-Assisted Versus Standard Training on Motor Function Following Subacute Rehabilitation After Ischemic Stroke - a Randomised Controlled Trial Nested in a Prospective Cohort.

Background:

Stroke is the collective term for acute focal injuries to the central nervous system (CNS) caused by a disturbance in the blood circulation of the brain i.e., cerebral infarction (ischemic stroke) or intracerebral hemorrhage (hemorrhagic stroke). On an annual basis, 113,000 UK citizens and 12,000 Danish citizens are hospitalised following a stroke, and worldwide stroke is one of the leading causes of disability. Stroke-affected individuals may display residual impairments in motor, physical and cognitive functions along with mental fatigue and depression. Body weight unloading (BWU) has been suggested as a method of training for people with neurological disorders suffering from severe limitations in walking ability. BWU is the application of a vertical upwards force on the body centre of mass, thereby alleviating individuals of supporting their own body weight against gravity. However, the efficacy of BWU-based training is unclear. Therefore, the aim of the present study is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.

Trial design overview:

Randomised, assessor-blinded, two-arm, multicentre trial. Participants will be recruited through Odense University Hospital, Herlev Gentofte Hospital and Rigshospitalet. Stroke-affected patients are recruited to the prospective cohort 3 months post-stroke. Stroke-affected individuals will be recruited to the RCT from the prospective cohort 6 months post-stroke and randomised 1:1 for robot-assisted training (intervention group) or standard training (active control group). Cohort participants not eligible and/or interested in participation in the RCT study will continue their participation in the prospective cohort.

The RCT study compares training with the robot-assisted body weight unloading to standard training without the robot. Training programs will be matched for total hours allocated to training and will consist of 2 sessions per week with a physiotherapist (one-on-one) and last 6 months (48 training sessions in total). Each session will last 60 minutes, 75 minutes and 90 minutes during the first, middle and last two months of the training program, respectively. Thus, INT and CON are matched for training time, but the effective training volume (resistance times repetitions) is not controlled.