High-dose high-intensity Queen Square upper-limb rehabilitation for people with chronic stroke (INTENSIVE): protocol for a single-centre, randomised controlled trial

Introduction There is currently insufficient high-quality evidence to make general recommendations about high-dose high-intensity upper-limb rehabilitation programmes. Here we describe a randomised controlled trial that will determine the efficacy of two forms of high-dose, high-intensity upper-limb rehabilitation provided in a rehabilitation unit setting. Methods and analysis Patients with moderate upper-limb impairment (n=105, at least 6 months after stroke) will be randomised to either (1) high-dose high-intensity conventional upper-limb rehabilitation, (2) high-dose high-intensity virtual reality-based upper-limb rehabilitation and (3) usual care (a waiting list control group). Groups 1 and 2 will receive a minimum of 45 hours of active time on task over 3 weeks. Outcome measures will be collected at (T1) baseline; (T2) immediately post intervention and (T3) 3 months after the intervention has finished. The primary outcome measure will be the Fugl-Meyer Upper Extremity Assessment at 3 months after the intervention. Secondary outcome measures will be clinical, kinematic and neurophysiological using transcranial magnetic stimulation and electroencephalography. Explanatory measures will include MRI-based markers for integrity of the corticospinal tract, dorsal column-medial lemniscal pathway, grey and white matter and lesion load. The aim is to detect a difference of 7.25 points on the Fugl-Meyer Upper Extremity Assessment between each treatment group and the waitlist control group, with a power of 0.9 and significance of 0.025 (to account for two primary analyses). Analysis of change in the primary and secondary outcome measures will be performed using mulitple regression analysis. Ethics and dissemination The study protocol (V.1) has been approved by the Wales Research Ethics Committee 2 Cardiff (Rec reference: 22/WA/0065) on 15 March 2022. All recruited participants will provide informed consent. Trial results will be disseminated through peer-reviewed publications, presentations at major stroke/neurorehabilitation conferences and outreach to relevant stakeholder communities. Trial registration number NCT05527262 .