Prospective clinical study of rehabilitation interventions with multisensory interactive training in patients with cerebral infarction: study protocol for a randomised controlled trial

BACKGROUND Multisensory interactive training has an increasingly prominent role in stroke rehabilitation. Currently, there is insufficient evidence to demonstrate its efficacy on gait improvement, upper limb and lower limb functional improvement, global motor function and cognitive improvement. A recent Cochrane review confirmed that published studies on virtual reality (VR) training have the limitations of lack of powered sample size, did not evaluate the benefits over a long-term period and lacked trial quality on cognitive function. Another systematic review also concluded that the evidence for the use of VR in gait and balance improvement is limited. This study investigates the effects of multisensory training on gait pattern, upper and lower limb biomechanics, upper limb gross and fine motor functions, and lower limb functional recovery over a medium- to long-term period. METHODS Two hundred and twenty-four acute stroke patients will be recruited from a single centre over a period of 6 years. Participants will be randomly assigned to either conventional therapy or conventional therapy with VR training. Outcomes will be recorded at baseline, post intervention and at 3, 6 and 12 months post intervention. Primary outcome measure is gait speed. Secondary outcome measures include kinematic data of upper and lower limb motion, muscle tone, Action Research Arm Test and Short Orientation Memory Concentration Test. DISCUSSION The results of this trial will provide in-depth understanding of the effect of early VR interventions on gait, upper and lower limb biomechanics and how it may relate to changes in functional outcomes and muscle tone. TRIAL REGISTRATION Chinese Clinical Trial Registry (Registration No.: ChiCTR-IOC-15006064 ). Registered on 11 May 2015.