Background: Patients with Mild Cognitive Impairment (MCI) and Vascular Cognitive Impairment (VCI) are at a high risk of progressing to dementia. Recent guidelines indicate the importance of promoting multidimensional and multi-domain interventions to prevent further decline. Due to its growing effectiveness, comparable to conventional face-to-face interventions, the use of technology is gaining relevance. Tele-rehabilitation systems have the potential to engage patients in multi-dimensional activity programs and to guarantee a low-cost continuum of care through remote control. A possible limitation of such programs is represented by the lack of familiarization with technology and computers in elderly people. The purpose of this study is to describe the feasibility, adherence, and appreciation of the GOAL Tele-R system, administered by a web-application through remote control in patients with MCI/VCI.Methods: Feasibility of the Tele-R system was evaluated by means of distribution of patients' attrition along the study phases, controlling for potential systematic bias in drop-out rates due to the technological device. Adherence was evaluated analyzing drop-out rates and indexes of carried out activities. Patients' appreciation was analyzed through ad hoc satisfaction questionnaire items.Results: Out of 86 approached patients, 25 (29%) were not enrolled, 30 (35%) dropped-out after randomization, and 31 (36%) completed the study (standard care group n = 12, the tele-R group n = 19). Compared to the tele-R group, rates of drop-outs resulted significantly higher for the standard care group (34 vs. 62%, respectively, p = 0.029). Taking into account baseline characteristics, females resulted in a statistically significant higher rate of drop-outs compared to males (66 vs. 27%, respectively, p = 0.003). Overall adherence to the proposed activities was 84% (85% for cognitive module and 83% for physical activity module). Concerning satisfaction, participants provided a good mean level of appreciation (3.7 ± 0.8, range 1–5), a positive feedback for usability, and a subjective perception of cognitive, emotional, and physical benefits due to the training.Conclusion: The GOAL Tele-R system seems a feasible technological rehabilitation program, reaching an acceptable level of adherence and appreciation in patients with an MCI/VCI condition.Clinical Trial Registration:www.ClinicalTrials.gov, ID: NCT03383549 (registration date: 26/dec/2017).
Background: People living with Mild Cognitive Impairment (MCI) and Vascular Cognitive Impairment (VCI) are persons who do not fulfill a diagnosis of dementia, but who have a high risk of progressing to a dementia disorder. The most recent guidelines to counteract cognitive decline in MCI/VCI subjects suggest a multidimensional and multi-domain interventions combining cognitive, physical, and social activities. The purpose of this study is to test an innovative service that provides a multi-dimensional tele-rehabilitation program through a user-friendly web application. The latter has been developed through a participatory design involving MCI specialists, patients, and their caregivers. Particularly, the proposed tele-rehabilitation program includes cognitive, physical, and caregiver-supported social activities. The goal is to promote and preserve an active life style and counteract cognitive decline in people living with MCI/VCI.Methods:The study is a randomized controlled trial. Sixty subjects will be randomly assigned to the experimental group, who will receive the tele-rehabilitation program, or the control group, who will not receive any treatment. The trial protocol comprises three steps of assessment for the experimental group: at the baseline (T_0), after tele-rehabilitation program (T_1) and at follow-up after 12-months (T_2). Differently, the control group will be assessed twice: at the baseline and at 12-months follow-up. Both the experimental and the control group will be assessed with a multidimensional evaluation battery, including cognitive functioning, behavioral, functional, and quality of life measures. The tele-rehabilitation program lasts 8 weeks and includes cognitive exercises 3 days a week, physical activities 2 days a week, and social activities once a week. In addition, group will be given an actigraph (GENEActiv, Activisinghts Ltd., Cambridgshire, UK) to track physical and sleep activity.Discussion:Results of this study will inform on the efficacy of the proposed tele-rehabilitation to prevent or delay further cognitive decline in MCI/VCI subjects. The expected outcome is to counteract cognitive decline and improve both physical functioning and quality of life.Ethics and Dissemination:The study is approved by the Local Ethics Committee and registered in https://clinicaltrials.gov (NCT03383549). Dissemination will include submission to a peer-reviewed journal, patients, and healthcare magazines and congress presentations.Trial Registration: ClinicalTrials.gov ID: NCT03383549 (registration date: 26/dec/2017)Trial Funding: Bando FAS Salute 2014 Regione ToscanaVersion Identifier: ver 5—16/11/2018
Gait abnormalities such as high stride and step frequency/cadence (SF—stride/second, CAD—step/second), stride variability (SV) and low harmony may increase the risk of injuries and be a sentinel of medical conditions. This research aims to present a new markerless video-based technology for quantitative and qualitative gait analysis. 86 healthy individuals (mead age 32 years) performed a 90 s test on treadmill at self-selected walking speed. We measured SF and CAD by a photoelectric sensors system; then, we calculated average ± standard deviation (SD) and within-subject coefficient of variation (CV) of SF as an index of SV. We also recorded a 60 fps video of the patient. With a custom-designed web-based video analysis software, we performed a spectral analysis of the brightness over time for each pixel of the image, that reinstituted the frequency contents of the videos. The two main frequency contents (F1 and F2) from this analysis should reflect the forcing/dominant variables, i.e., SF and CAD. Then, a harmony index (HI) was calculated, that should reflect the proportion of the pixels of the image that move consistently with F1 or its supraharmonics. The higher the HI value, the less variable the gait. The correspondence SF-F1 and CAD-F2 was evaluated with both paired t-Test and correlation and the relationship between SV and HI with correlation. SF and CAD were not significantly different from and highly correlated with F1 (0.893 ± 0.080 Hz vs. 0.895 ± 0.084 Hz, p < 0.001, r2 = 0.99) and F2 (1.787 ± 0.163 Hz vs. 1.791 ± 0.165 Hz, p < 0.001, r2 = 0.97). The SV was 1.84% ± 0.66% and it was significantly and moderately correlated with HI (0.082 ± 0.028, p < 0.001, r2 = 0.13). The innovative video-based technique of global, markerless gait analysis proposed in our study accurately identifies the main frequency contents and the variability of gait in healthy individuals, thus providing a time-efficient, low-cost means to quantitatively and qualitatively study human locomotion.
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