Robotic Arm Intervention for Stroke rEcovery (RAISE): A pilot randomised controlled trial

Participants in the intervention group will receive a minimum of 40 hours additional therapy delivered five days per week (Mon-Fri) over four weeks, equating to approximately two hours per day. This therapy will be comprised of task specific motor training (75mins) and robotic therapy (45mins) delivered by a trained occupational therapist or physiotherapist. Task specific motor training will be delivered using a specifically developed manual, tailored to the individual's abilities. Activities will include tasks such as reaching for a cup to practice shoulder forward flexion and external rotation or attaching pegs to a line to practice train finger dexterity. Each activity within the manual has pre-planned levels of difficulty and modifications that may be enacted in order to individualise the activity to the participants ability. Robotic therapy will be delivered using a portable robotic exoskeleton with real time visual biofeedback and electromyography (EMG) activation (see doi: 10.1186/s12984-021-00867-7). The device is comprised of a forearm and hand support and simple visual display. Participants will be asked to attempt to extend their wrist and fingers. The EMG sensor will register muscle activity as the person attempts the movement, activating the device and moving the hand into wrist and finger extension. Intervention will primarily be delivered within a clinical setting, with the option for intervention delivery in the participant's home or via telehealth as required at the discretion of the site investigator. In clinical settings, therapy may be delivered using a combination of individual and semi-supervised sessions (with up to three participants: 1 therapist). Program adherence data will be collected by recording the duration of sessions (time spent active vs inactive), level of difficulty of therapy tasks (as reported by participants) and amount of repetitions completed. Acceptability of the high dose motor retraining program will be measured via i) the theoretical framework of acceptability (TFA) questionnaire, which consists of seven component constructs of acceptability of an intervention and an overall acceptability measure and ii) The 10 question System Usability Scale (SUS), a validated tool, which measures a users’ experience of technology. This data will be collected by members of the research team.