Effects of kinesthetic cues supported by physiotherapist during a motor training intervention with virtual reality-based games on functioning in people with Parkinson’s disease: A prospective, single-blinded, parallel-group, randomized clinical trial

Background It’s been suggested that kinesthetic cues (KC) could be a useful tool in helping individuals improve their motor learning process by facilitating muscle activation. However, while virtual reality-based games (VRG) are becoming more popular as a intervention tool, the potential effects of KC on this kind of intervention have yet to be investigated in people with Parkinson’s disease (PwPD). Therefore, this study aimed to compare the effects of motor intervention using VRG coupled or not with KC provided by a physiotherapist (PT) during training on the functioning of PwPD. Methods Thirty-eight PwPD in 1-3 Hoehn and Yahr (HY) stage were randomized into two groups: (1) VRG with KC Group (KCG), where KC was provided by manual assistance of a PT, and (2) VRG with NO KC group (NKCG), where no PT manual assistance was provided during the training. Both groups received 8 individual sessions with 50 minutes, twice a week, for 4 weeks: 10 minutes for warm-up and 40 minutes to play 4 games from XBOX 360 with Kinect® system. Outcomes were evaluated at three time points: (1) before training (BT), (2) 1 week after training (AT), and 8 weeks after that as follow-up (FU). To reach a comprehensive evaluation of functioning, several outcomes were adopted and categorized according to International Classification of Functioning Disability and Health (ICF): Geriatric Depression Scale (GDS); Montreal Cognitive Assessment (MOCA); Unified Parkinson Disease Rating Scale (UPDRS) - [section 3][1] (UPDRS-III); and Rapid Turns Test (RTT) used to assess motor and non-motor alteration into Function domain; Balance Evaluation Systems Test (BESTest); Falls Efficacy Scale International (FES-I); Thirty-Second Walk Test (30sWT); Six-Minute Walk Test (6mWT); 5 Times Sit to Stand Test; and UPDRS section II (UPDRS-II) used to assess motor performance into Activity domain, and finally, the Parkinson Disease Questionnaire (PDQ-39) to assess quality of life into Participation domain. Results ANOVA for repeated measures showed a significant effect for evaluation-time factor only (p-value<.001), (no effect for group or evaluation-time X group interaction) for all measures of three ICF domains, excluding GDS and 6mWT. The Tukey post-hoc test confirmed significant improvements in AT that remained at FU. Conclusions: A motor intervention using VRG can improve the functioning in terms of Function, Activity, and Participation of PwPD, regardless of the KC provided by PT during the training. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ClinicalTrials.gov with trial registration number [NCT04717271][2]. ### Funding Statement This article was produced as part of the activities of FAPESP Research, Innovation and Dissemination Center for Neuromathematics (grant #2013/ 07699-0, S.Paulo Research Foundation). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: his study was conducted in accordance with the Declaration of Helsinki and approved by the Research Ethics Committee of the Faculty of Medicine of the University of Sao Paulo (protocol code 79419517,4,0000,0065, approval date 21 February 2018. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript [1]: #sec-14 [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04717271&atom=%2Fmedrxiv%2Fearly%2F2023%2F09%2F01%2F2023.08.30.23294862.atom