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Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies.

ABSTRACT: BACKGROUND:Parkinson's disease is one of the most frequent causes of disability among the older adults. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidences suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation plays an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate the effectiveness of robotic-based intervention of the older adults with Parkinson's disease, designed to improve the gait and to reduce the risk of falling. METHODS:This study is a single-blinded randomized controlled trial. The primary outcomes are: risk of falling, gait performance and fear of falling measured through Performance-Oriented Mobility Assessment (POMA), instrumental gait analysis and Short Falls Efficacy Scale - International (FES-I), respectively. One hundred ninety-five patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tymo system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6?months, 1?year and 2?years from the end of the treatment. A 10-treatment session will be conducted, divided into 2 training sessions per week, for 5?weeks. The control group will perform traditional therapy sessions lasting 50?min. The technological intervention group will carry out 30?min of traditional therapy and 20?min of treatment with a robotic system. DISCUSSION:The final goals of the present study are to propose a new approach in the PD rehabilitation, focused on the use of robotic device, and to check the results not only at the end of the treatment but also in the long term. TRIAL REGISTRATION:NCT04087031, registration date September 12, 2019.

SUBMITTER: Bevilacqua R

PROVIDER: S-EPMC7222584 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies.

Bevilacqua Roberta R Maranesi Elvira E Di Rosa Mirko M Luzi Riccardo R Casoni Elisa E Rinaldi Nadia N Baldoni Renato R Lattanzio Fabrizia F Di Donna Valentina V Pelliccioni Giuseppe G Riccardi Giovanni Renato GR

BMC neurology 20200513 1

<h4>Background</h4>Parkinson's disease is one of the most frequent causes of disability among the older adults. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on em ...[more]

PMID: 32404132

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Project description:BackgroundStroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke, and improving walking function is often a key component of any rehabilitation program. To achieve this goal, a robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects.MethodsIn this single-blind randomized controlled trial, we will include 152 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. Twenty treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group, using the G-EO system, will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, and acceptance of the technology, will be carried.DiscussionThe final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation, focused on the use of a robotic device, in order to obtain the beneficial effects of this treatment.Trial registrationClinicalTrials.gov NCT04087083 . Registered on September 12, 2019.

Project description:BACKGROUND:The increase in life expectancy and recent advancements in technology and medical science have changed the way we deliver health services to the aging societies. Evidence suggests that home telemonitoring can significantly decrease the number of readmissions, and continuous monitoring of older adults' daily activities and health-related issues might prevent medical emergencies. OBJECTIVE:The primary objective of this review was to identify advances in assistive technology devices for seniors and aging-in-place technology and to determine the level of evidence for research on remote patient monitoring, smart homes, telecare, and artificially intelligent monitoring systems. METHODS:A literature review was conducted using Cumulative Index to Nursing and Allied Health Literature Plus, MEDLINE, EMBASE, Institute of Electrical and Electronics Engineers Xplore, ProQuest Central, Scopus, and Science Direct. Publications related to older people's care, independent living, and novel assistive technologies were included in the study. RESULTS:A total of 91 publications met the inclusion criteria. In total, four themes emerged from the data: technology acceptance and readiness, novel patient monitoring and smart home technologies, intelligent algorithm and software engineering, and robotics technologies. The results revealed that most studies had poor reference standards without an explicit critical appraisal. CONCLUSIONS:The use of ubiquitous in-home monitoring and smart technologies for aged people's care will increase their independence and the health care services available to them as well as improve frail elderly people's health care outcomes. This review identified four different themes that require different conceptual approaches to solution development. Although the engineering teams were focused on prototype and algorithm development, the medical science teams were concentrated on outcome research. We also identified the need to develop custom technology solutions for different aging societies. The convergence of medicine and informatics could lead to the development of new interdisciplinary research models and new assistive products for the care of older adults.

Project description:IntroductionGuidelines endorse to implement an integrated and multidisciplinary team approach in the management of people with Parkinson's disease (PD). However, there is no net and clear finding that shows the supremacy of multidisciplinary team interventions over conventional interventions for people with PD. Therefore, we perform a systematic review and meta-analysis to determine the supremacy of multidisciplinary interventions for people with PD.MethodsA systematic review and meta-analysis of randomized controlled trials were conducted. PubMed, Physiotherapy Evidence Database, Cochrane Library, and Google Scholar were searched from inception until May 2021. Randomized controlled trials comparing multidisciplinary intervention with conventional physiotherapy were included. The outcome measures were gait balance, disability status, quality of life, and depression level. The PEDro scale was used to systematically appraise methodological quality. Two reviewers screened, extracted, and performed a quality assessment of included studies independently. Review Manager V.5.4 (Cochrane Collaboration) software was used for statistical analysis. Heterogeneity was analyzed using I2 statistics, and a standardized mean difference with 95% CI and Pvalue was used to calculate the treatment effect for outcome variables.ResultsA total of 6 studies with 1260 participants were included. The average PEDro methodological quality score was 6.67. No statistically significant difference between multidisciplinary and conventional rehabilitation on functional capacity (SMD: 0.69; 95% CI: -0.13, 1.51; P=0.10), disability status (SMD: 0.65; 95% CI: -0.16, 1.46; P=0.11), and quality of life (SMD: 0.28; 95% CI: -0.31, 0.59; P=0.08) was found. However, there is a statistically significant improvement in caregivers' anxiety levels in the multidisciplinary group (SMD: 0.39; 95% CI 0.06, 1.73; P=0.02).ConclusionThis systematic review and meta-analysis show no significant difference between multidisciplinary and conventional rehabilitation on functionality, disability, and quality of life. Caregivers' anxiety levels show improvement following multidisciplinary interventions. However, large-scale studies with long-term follow-up were required for concrete and clinical recommendations.

Project description:The Lancashire and Cumbria Innovation Alliance (LCIA) Test Bed is a partnership between the National Health Service in England, industry (led by Philips) and Lancaster University. Through the implementation of a combination of innovative health technologies and practices, it aims to determine the most effective and cost-effective ways of supporting frail older people with long-term conditions to remain well in the community. Among the Test Bed's objectives are to improve patient activation and the ability of older people to self-care at home, reduce healthcare system utilisation, and deliver increased workforce productivity.Patients aged 55 years and over are recruited to four cohorts defined by their risk of hospital admission, with long-term conditions including chronic obstructive pulmonary disease, dementia, diabetes and heart failure. The programme is determined on an individual basis, with a range of technologies available. The evaluation is adopting a two-phase approach: phase 1 includes a bespoke patient survey and a mass matched control analysis; and phase 2 is using observational interviews with patients, and weekly diaries, action learning meetings and focus groups with members of staff and other key stakeholders. Phase 1 data analysis consists of a statistical evaluation of the effectiveness of the programme. A health economic analysis of its costs and associated cost changes will be undertaken. Phase 2 data will be analysed thematically with the aid of Atlas.ti qualitative software. The evaluation is located within a logic model framework, to consider the processes, management and participation that may have implications for the Test Bed's success.The LCIA Test Bed evaluation has received ethical approval from the Health Research Authority and Lancaster University's Faculty of Health and Medicine Research Ethics Committee. A range of dissemination methods are adopted, including deliberative panels to validate findings and develop outcomes for policy and practice.

Project description:BackgroundThe COVID-19 pandemic has led to worldwide implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine, and home confinement measures. Such restrictions on activities of daily life and separation from loved ones may lead to social isolation and loneliness with health-related consequences among community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, inadequate access to health care and social support services may aggravate chronic conditions. Home-based technological interventions have emerged for combating social isolation and loneliness, while simultaneously preventing the risk of virus exposure.ObjectiveThe aim of this cohort study is to explore, analyze, and determine the impact of social isolation on (1) cognition, quality of life, mood, technophilia, and perceived stress among community-dwelling older adults with mild cognitive impairment or mild dementia and on the caregiver burden; (2) access to and utilization of health and social care services; and (3) cognitive, social, and entertainment-related uses of information and communication technologies.MethodsThis study will be conducted in Málaga (Andalucía, Spain). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia and his/her informal caregiver, will be contacted by telephone. Potential respondents will be participants of the following clinical trials: support, monitoring, and reminder technology for mild dementia (n=100) and television-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (n=100).ResultsAs of May 2021, a total of 153 participants have been enrolled and assessed during COVID-19 confinement, of whom 67 have been assessed at 6 months of enrollment. Changes in the mean values of the variables will be analyzed relative to baseline findings of previous studies with those during and after confinement, using repeated-measures analysis of variance or the nonparametric Friedman test, as appropriate. The performance of multivariate analysis of covariance (ANCOVA) to introduce potential covariates will also be considered. Values of 95% CI will be used.ConclusionsIf our hypothesis is accepted, these findings will demonstrate the negative impact of social isolation owing to COVID-19 confinement on cognition, quality of life, mood, and perceived stress among community-dwelling older adults with mild cognitive impairment and mild dementia, the impact on technophilia, caregiver burden, the access to and utilization of health and social care services, and the cognitive, social, and entertainment-related use of information and communication technologies during and after COVID-19 confinement.Trial registrationClinicalTrials.gov NCT04385797; https://clinicaltrials.gov/ct2/show/NCT04385797.International registered report identifier (irrid)DERR1-10.2196/26431.

Dataset Information

Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies.

Publications

Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies.

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