key: cord-0306161-eexr3un2 authors: Gatica-Rojas, V.; Cartes-Velasquez, R.; Soto-Poblete, A.; Lizama, L. E. C. title: Postural control telerehabilitation with a low-cost virtual reality protocol for children with cerebral palsy: Protocol for a clinical trial. date: 2022-04-28 journal: nan DOI: 10.1101/2022.04.25.22274289 sha: 2c172751f3d90b62326dcf00d6a067bfaa3168ab doc_id: 306161 cord_uid: eexr3un2 Objective To establish the feasibility and effectiveness of a rehabilitation programme using low-cost virtual reality aimed at improving postural control in children with cerebral type palsy spastic hemiplegia. It also seeks to compare low-cost virtual reality under two delivery modalities, telerehabilitation (TR) and face-to-face (FtF). Methods Randomized controlled clinical trial from the ACTRN platform ACTRN12621000117819. Eighteen sessions of low-cost virtual reality therapy will be provided through both, FtF and TR modalities using a Nintendo Wii balance board. Each programme will last for 6 weeks and will consist of 3 sessions per week of 25 minutes each. The participants will include 40 patients diagnosed with cerebral palsy type spastic hemiplegia. Twenty participants for each group. Participants will be assessed at baseline, by the end of weeks 2, 4, and 6, and at weeks 8 and 10 (post-intervention follow-ups). Clinical measures include the Modified-Modified Ashworth Scale for lower limbs, Modified Ashworth Scale for upper limbs, timed up-and-go tests, the timed one-leg standing and 6-minute walk test. Posturographic measures, including sway area and velocity, under six conditions will be used: 2 statics and 4 dynamic conditions, which include voluntary sway in the mediolateral direction following a metronome set at 30Hz and 60Hz, and sway while playing 2 different videogames. Results This study provides an assessment of the feasibility and effectiveness of an affordable rehabilitation programme using low-cost virtual reality aimed at improving postural control in children with cerebral palsy. Conclusion Rehabilitation programme using low-cost virtual reality will improve postural control in children with cerebral palsy type spastic hemiplegia and this programme delivered using TR will be as effective as a FtF modality. The TR programme has be designed to expand the coverage of physiotherapy services for children with cerebral palsy in low-resource settings and in remote areas. CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 28, 2022. Low-cost virtual reality exergames are well-accepted by children and adolescents due to 87 their ludic, motivating and engaging features, which facilitate a nearly seamless 88 incorporation into TR. 16 However, research on TR using low-cost virtual reality is yet in its 89 infancy as high-level evidence comparing this modality with standard FtF interventions is 90 still lacking. It is noteworthy that low-cost virtual reality TR also brings the possibility to 91 standardize rehabilitation interventions, which is a pending task in neurorehabilitation. 18 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted April 28, 2022. This clinical trial protocol seeks to establish the feasibility and effectiveness of a 93 rehabilitation programme using low-cost virtual reality aimed at improving postural control 94 in children with CP. It also seeks to compare low-cost virtual reality under two delivery 95 modalities, telerehabilitation (TR) and face-to-face (FtF, control group). We hypothesize 96 that a rehabilitation programme using low-cost virtual reality will improve postural control 97 in children with CP and that this programme delivered using TR will be as effective as a 98 FtF modality. The TR programme is designed to expand the coverage of physiotherapy 99 services for children with CP in low-resource settings and in remote areas, but also to 100 provide access to physiotherapy during restricted mobility as in the case of recent COVID-101 19-related lockdowns. This study was supported by the Innovation Fund for Competitiveness, Maule Regional Written informed consent will be obtained from parents and participants over 7 years old; 116 verbal assent will be obtained from younger children. This study compares the effects of low-cost virtual reality in two distinct settings. The first 120 setting is clinical (Telerehabilitation Technology Centre and Neurosciences in Human 121 Movement, Universidad de Talca, Talca, Chile) and in which low-cost virtual reality is 122 delivered in a FtF modality (control group) with therapist interacting directly with the . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted April 28, 2022. ; https://doi.org/10.1101/2022.04.25.22274289 doi: medRxiv preprint 5 123 patient. The second setting is a remote facility with no therapist on-site for the delivery of 124 low-cost virtual reality through TR, and could be an at-home, school, or rehabilitation 125 centre. The choice of setting will depend on each participant's adequate access to space and 126 equipment. All assessments will be conducted at the facility in which therapy was 127 conducted. This study will compare the effects of low-cost virtual reality delivered through FtT and TR 147 modalities. The low-cost virtual reality will consist of in using a Nintendo Wii balance 148 board to play 4 exergames. In the FtF group therapy will be provided by a physiotherapist 149 with experience in the use of exergames for rehabilitation. In the TR modality, the 150 intervention (low-cost virtual reality) will be delivered by the patient's parent or caregivers. In total, both groups (FtF and TR) will receive 18 sessions of low-cost virtual reality 152 divided in 3 sessions per week (Monday, Wednesday, and Friday) over a period of 6 weeks. Each session will last for 25 minutes in which each participant will perform three series of . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 28, 2022. ; https://doi.org/10.1101/2022.04.25.22274289 doi: medRxiv preprint 6 154 exergames resting 2 minutes in between. The first two series will include Snowboard, 155 Penguin Slide, and Super Hula Hoop. The first series is played with arms on the side and 156 the second one with hands on the waist to avoid the potential effect of training under one or 157 the other strategy. The third series is deep breathing in the Yoga game. During the first 2 158 weeks of training (first 6 sessions), patients will receive manual guidance and verbal 159 instructions after which (7 th session onwards) only verbal instructions will be provided by 160 the parents, caregiver, or physiotherapist. Children and adolescents with congenital SHE-CP will be recruited from the Rehabilitation 208 Institute, Talca, Chile. This is an outpatient clinic that provides rehabilitation services to 209 patients with neurological disorders including CP children. It is noteworthy, that patients 210 from this centre will have little or no experience using a Nintendo Wii balance board. An 211 experienced staff of health professionals, comprised of a physician and two physical 212 therapists, will recruit participants according to the inclusion/exclusion criteria. Screening 213 for potential participants will continue until the calculated sample size is achieved. assessments. An employee outside the research team will feed data into the computer in 229 separate datasheets so that the researchers can analyse data without having access to 230 information about the allocation. All raw data will be electronically saved in coded text files whereas calculated and clinical 232 outcomes measures will be saved in a coded Excel spreadsheet. Data backups will be made 233 every week. Demonstrating that a TR is as efficient as a FtF intervention is crucial to adopt TR as an protocol we hypothesize that low-cost virtual reality will improve postural control and that . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 28, 2022. Home-based therapies for patients with CP seem to be feasible; however, the available 326 studies have used diverse methods and strategies, and, therefore, it is hard to determine the 327 impact of these kinds of therapies. 49 An efficient way to deliver these home-based therapies 328 is using TR, which appears to be an option to improve physical function in patients with 329 disabilities. However, most research has included low-quality evidence studies that make it 330 impossible to determine the effectiveness of TR. 50 In the case of patients with CP, two 331 studies have shown promising results, 13,14 but the evidence is far from conclusive. This will be the first study assessing the effects of a six-week exercise programme remote 363 (TR) using a Nintendo Wii balance board to improve standing balance in children and 364 adolescents with CP type spastic hemiplegia compared with the effects of an FtF modality. This trial will provide evidence on the effectiveness of the Nintendo Wii for improving 366 standing balance in patients with CP, a matter in which the current evidence is lacking. This 367 low-cost virtual reality TR programme is designed to expand the coverage of physical 368 therapy services for patients with CP in low-resource settings using affordable products, 369 such as the Nintendo Wii balance board. The scientific contribution towards improving 370 static or dynamic standing balance will support the idea that affordable technological tools . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 28, 2022. . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 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