Effectiveness of robot-assisted virtual reality mirror therapy for upper limb motor dysfunction after stroke: study protocol for a single-center randomized controlled clinical trial

Abstract

Background Upper limb motor dysfunction is a common sequela of stroke, and its clinical efficacy needs to be improved. This protocol describes a trial to verify the clinical efficacy of robot-assisted virtual reality mirror therapy (RAVRMT) in improving upper limb motor dysfunction in stroke patients, and to explore the central mechanism by using functional magnetic resonance imaging (fMRI). Methods This trial will be a single-center, assessor-blinded, randomized controlled clinical study. Thirty-two eligible patients will be randomly divided into 2 groups according to the ratio of 1:1, namely virtual reality mirror therapy (VRMT) group and robot-assisted virtual reality mirror therapy (RAVRMT) group. The interventions will be performed once a day for 4 weeks. Primary outcome is Fugl–Meyer motor function assessment-Upper Extremity (FMA-UE), secondary outcomes are the Montreal Cognitive Assessment (MoCA), activities of daily living (ADL), quality of life (QOL), the pain visual analogue scale (VAS-pain) and fMRI. Adverse events will be recorded, and severe adverse events will be used as criteria to discontinue the intervention. Discussion Combined application of robot-assisted therapy and virtual reality mirror therapy could theoretically activate mirror neuron system and reward circuits to a greater extent, but further high-quality research is needed. The results of this trial will determine whether RAVRMT could better improve upper limb motor dysfunction after stroke and explore its central mechanism using fMRI. Trial registration This trial was prospectively registered at ClinicalTrials.gov (ChiCTR2200061721; 01 July 2022).

360° immersive virtual reality-based mirror therapy for upper extremity function and satisfaction among stroke patients: a randomized controlled trial

“… 25 , 26 Previous studies have demonstrated the effectiveness of virtual reality-based MT for the upper extremity rehabilitation of stroke survivors. 27 , 28 However, to the best of our knowledge, no study has yet attempted to implement immersive virtual reality-based MT using a 360° camera and HMD that reflects the patient’s own hand in the virtual environment during treatment. For instances, Heinrich et al 29 applied VRMT to upper limb rehabilitation after stroke, testing its feasibility.…”

Biopsychosocial effects and experience of use of robotic and virtual reality devices in neuromotor rehabilitation: A study protocol

“…So far, diverse clinical trials protocols have been recently developed with the purpose of estimating the motor and functional benefits of RAT and VR-based therapy in different clinical populations [76][77][78][79][80][81][82][83]. Nevertheless, it must be noted that for the most, although factors like patient's mental status or technology acceptance were investigated, these were considered as secondary outcomes essentially.…”

The Effectiveness of Mirror Therapy in Stroke Patients: A Systematic Review

“…No conclusions can be drawn to support effectiveness MT for patients in the acute and sub-acute stages. Seven studies (Hung et al 2022); (Wei et al 2022); (Miclaus et al 2021);(Palomo-Carrión et al 2021) (Noureen et al 2022) (Hsieh et al 2020) (Gandhi et al 2020) in this review have included participants in the chronic stage and acute but the majority of them consisted of one lowquality RCT (Wei et al 2022) and 3 experimental studies (Miclaus et al 2021);(Palomo-Carrión et al 2021) (Noureen et al 2022) and two high-quality RCTs (Hung et al 2022) and (Gandhi et al 2020) and 1 high-quality experimental study (Hsieh et al 2020), Furthermore, all case studies used a combination of interventions. Remember the lack of high-quality evidence, it is difficult to conclude that the chronic stage is the optimal time to use this approach.…”

“…Research result demonstrated that RAT and VRMT are both highly effective for the treatment of improve upper extremity motor dysfunction in stroke patients with activated brain networks associated with movement and circuitry. This is too relevant to the study (Wei et al 2022) The number of samples is 32 people carried out for 4 weeks, with a frequency of once a day and the implementation time is about 20 minutes. The results showed that RAVRMT can improve upper extremity motor dysfunction after stroke better and explored its central mechanism using fMRI.…”

“…Muscle strength in post-stroke patients before being given mirror intervention therapy based on the articles reviewed in this review (Hung et al 2022); (Wei et al 2022); (Miclaus et al 2021);(Palomo-Carrión et al 2021); (Noureen et al 2022); (Hsieh et al 2020); (Gandhi et al 2020), reported muscle strength in post-stroke patients before being given mirror therapy intervention post-stroke patient's muscle strength is still experiencing hemiparesis. Meanwhile muscle strength in post-stroke patients after being given a mirror therapy intervention has increased muscle in the part of the body that has hemiperasis thereby increasing the patient's independence (Hung et al 2022); (Wei et al 2022); (Miclaus et al 2021);(Palomo-Carrión et al 2021); (Noureen et al 2022); (Hsieh et al 2020); (Gandhi et al 2020), thus mirror therapy can increase muscle strength in poststroke patients.…”