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

Stroke is the third leading cause of disability worldwide [1, 2]. Stroke survivors often have an abnormal hemiparetic gait pattern that is characterised by decreased gait speed [3], altered kinematics of hip, knee and ankle joints during a gait cycle [4] and functional impairment of lower and upper extremities. Impaired ability to walk is one of the most devastating consequences and gait recovery is often regarded as a primary objective in stroke rehabilitation [5]. It is becoming widely recognised that multisensory VR training is an important component of stroke rehabilitation and one that has demonstrated potential to promote gait, lower and upper limb functional recovery, and thus increase quality of life.

Virtual reality (VR) has been subjected to intense research over the past decade as an intervention to promote functional recovery for patients with stroke. The virtual environment offers multisensory interaction and goal-orientated tasks that can stimulate active repetitive movements and offer instant feedback [6]. VR is relatively low cost and may be employed within home settings where patients live remotely or have other barriers to participate in intervention [7]. The concept of using commercial gaming (CG) systems to deliver VR interventions at home as part of the rehabilitation programme was well received among stroke survivors as they believed it to be beneficial for functional recovery [8]. Previous studies on VR interventions indicated that they may be more effective in improving gait, lower limb functions [9, 10] and upper limb functions [11] when compared to conventional therapy. Functional imaging studies have indicated that cortical reorganisation is associated with gait improvement post-VR interventions. The latest published meta-analysis [7] suggested that VR interventions are at least as effective as conventional physiotherapy in improving lower limb outcomes within the stroke population.

Gait performance is a predictor for disability [12, 13], mortality and morbidity [14]. Early intervention with physical therapy to restore gait function had been shown to improve motor function and decrease the subsequent disability when compared to intervention provided at the subacute or chronic stages [15]. Despite the reported positive results for VR interventions, published systematic reviews concluded that the evidence for VR in gait, lower limb functions and balance improvement is limited [16], particularly for stroke patients during the acute stage [17]. It was argued that since most of the neuroplasticity activity took place within the first month of stroke occurrence, VR intervention provided during the acute stage of stroke is likely to lead to better clinical outcomes for gait and lower limb functions [18]. A Cochrane review [19] also concluded that there was insufficient evidence to demonstrate the efficacy of VR training on gait speed and global motor function improvement due to a lack of powered sample size and did not evaluate the effectiveness of VR over a long-term period or post hospital discharge. Thus, little is currently known about the impact of VR on gait and lower limb functions during the acute stage and if the impact is sustainable in the long term.

The recovery of upper limb function to perform delicate motions, such as grasping, finger pinching and individual finger movement continues to be a challenge for stroke survivors [11]. Existing rehabilitation programmes, such as constrain-induced therapy, imagery training and bilateral training, have focussed on the improvement of upper limb gross motor skills [20‐22]. These training regimes have insufficient emphasis on fine motor skills and coordination of limb movements; thus, leading to reduced ability to carry out activities of daily living. Sophisticated robotic devices have been developed to provide the possibility to train hand and finger motor skills [11]. However, these types of devices are not easily accessible in most rehabilitation departments. In addition, fine motor movement involves the combination of cognitive and motor functions to plan and execute it. Cognitive function refers to the ability to process received information, and to take appropriate action accordingly [12]. Large numbers of stroke survivors have cognitive impairment which presents an additional challenge in upper limb functional recovery. Previous studies have indicated that cognitive function can be recovered through repetitious training [13]. Two Cochrane reviews [19, 23] suggest that VR interventions appear to be promising with moderate-quality evidence to support the beneficial effects on upper limb functional improvement. However, the number of studies available are too few and too small to draw conclusions on upper limb recovery and cognitive function improvements induced by VR interventions. In addition, most of the studies assessed gross motor function by functional outcome measures such as the Action Research Arm Test and the Fugl-Meyer Assessment of Motor Recovery. While they are validated clinical tests, several authors cast doubts on the use of functional outcomes to study motor recovery post stroke. It was argued that functional outcome measures only focussed on task accomplishment regardless of the quality of movement [24, 25]. Since motor compensation can affect [26, 27] task accomplishment, it is, therefore, essential to understand the impact of VR on motor performance measures and to cross reference with functional outcome measures.