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

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.

Study protocol for a feasibility study of an online educational programme for people working and living with persistent low back pain.

BACKGROUND: Low back pain (LBP) is the main cause of activity limitation and work absence across the world, leading to a high social and economic burden for individuals, families, the labour market and society. The overall aim of this multicentre study is to test the usability, acceptability and feasibility of an evidence-based, digital education programme for people living and working with persistent LBP who are in sedentary or physically demanding jobs and need advice on ergonomics, self-management of pain and healthy behavioural strategies. METHODS: This is the protocol of a multinational, multicentre, prospective uncontrolled feasibility study targeting people with persistent LBP in Lithuania, Northern Ireland, Italy, Sweden and Portugal. Eligible participants will be offered the opportunity to use the MyRelief educational platform as part of their care and will undergo evaluations at baseline (enrollment) and 1-month follow-up. Feasibility will be assessed using measures of recruitment and retention, intervention engagement, outcome measure completion rates and within-group effect sizes in response to the digital education programme. DISCUSSION: This study will identify the challenges and implications of delivering a digital training programme in advance of potentially delivering the programme via an online educational platform available on mobile devices. The findings will inform the design of a future randomised controlled trial if it proves feasible. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04673773 . Registered 17 December 2020.

Evaluation of the Italian version of the elderly mobility scale in older hospitalized patients.

Introduction: Reliable and valid assessment tools are needed to evaluate and predict physical function in older hospitalized patients. The aim of this study is to develop the Italian version of the Elderly Mobility Scale (I-EMS) and to evaluate its validity and inter-rater reliability for use with geriatric inpatients. Methods: The study consists of two phases: (i) translation, where EMS version 2 was translated into Italian by two teams, each comprising 2 bilingual physiotherapists; translations were back translated by 2 native English speakers, and a committee of 2 physiotherapists and 1 physician refined the initial I-EMS version, which was pilot-tested for clarity in a group of ten experienced geriatric physiotherapists; (ii) an observational study assessed I-EMS metrics (reliability, validity) in older Italian inpatients at IRCCS INRCA (Ancona, Italy) between September 2022 and April 2023. Results: No statistically significant differences were found between the scores of individual items and the total score assigned by different raters. The ICC for total I-EMS was 0.951, SEM was 1.10 and MDC95 was 3.06. The absolute agreement and weighted kappa for individual items ranged 80.32-100% and 8.2-1, respectively. The validity of I-EMS was supported by a significant (p < 0.05) correlation with the Barthel Index (r = 0.827 and 0.834 for the I-EMS administered by rater A and rater B, respectively). Conclusion: I-EMS showed good internal consistency and inter-rater reliability, and confirmed construct validity with respect to BI. Therefore, it can safely be used as an assessment tool for hospitalized Italian geriatric patients. Clinical trial registration: [ClinicalTrials.gov], [NCT05806242].

Acceptability and Preliminary Results of Technology-Assisted Balance Training in Parkinson's Disease.

(1) Background: Parkinson's Disease (PD) is one of the most common causes of disability among older individuals. The advanced stages of PD are usually characterized by postural instability and, as a consequence, falls. Those are among the main factors that determine the quality of life, as well as the morbidity and mortality of a person with PD. In the field of PD rehabilitation, robotics is also rapidly gaining ground. As a primary aim, we evaluate the acceptability of the technology integrated intervention, using the Psychosocial Impact of Assistive Devices Scale (PIADS), in order to analyze the attitude of the participants towards the Tymo® system. As a secondary outcome, we assess the result of the rehabilitation treatment integrated with the Tymo® system on several patient's features. (2) Methods: We studied a population of 16 patients with Parkinson's Disease. Each recruited subject completed 10 treatment sessions, organized as two training sessions per week, for 5 weeks. The intervention included 30 min of traditional therapy and 20 min of technological treatment with a robotic system. PIADS is composed of three subscales (Competence subscale, Adaptability subscale, Self-esteem subscale) ranging from -3 to +3, reflecting, respectively, a negative or positive feeling towards the device. (3) Results: The Competence subscale, measuring feelings of competence and usefulness, obtained a score of 1.24 (SD = 0.78). The score of Adaptability subscale, indicating a willingness to try out new things and to take risks, was 1.83 (SD = 0.65). Finally, the Self-esteem subscale, indicating feelings of emotional health and happiness, reached a score of 1.31 (SD = 0.72). Moreover, statistical analysis reveals a significant effect on balance performance after intervention. (4) Conclusions: This feasibility study represents a starting point in the use of technology in the rehabilitation pathway of patients affected by Parkinson's Disease. In fact, our results suggest that a standard therapy combined with an innovative treatment using Tymo® may be accepted by PD patients, which may benefit especially from preserving balance.

The Effect of Non-Immersive Virtual Reality Exergames versus Traditional Physiotherapy in Parkinson's Disease Older Patients: Preliminary Results from a Randomized-Controlled Trial.

(1) Background: Parkinson's disease (PD) is one of the most frequent causes of disability among older people. Recently, virtual reality and exergaming have been emerged as promising tools for gait and balance rehabilitation in PD patients. Our purpose is to evaluate an innovative treatment for older patients with PD, based on non-immersive virtual reality exergames, improving gait and balance and reducing falling risk. (2) Methods: Thirty PD patients were recruited and randomly divided into two groups, to receive a traditional rehabilitation (CG) or a technological rehabilitation (TG). (3) Results: A statistical improvement of balance at the end of treatments was observed in both groups (CG: 12.4 ± 0.7 vs. 13.5 ± 0.8, p = 0.017; TG: 13.8 ± 0.5 vs. 14.7 ± 0.4, p = 0.004), while the overall risk of falling was significantly reduced only in the TG (POMA Total: 24.6 ± 0.9 vs. 25.9 ± 0.7, p = 0.010). The results between groups shows that all POMA scores differ in a statistically significant manner in the TG, emphasizing improvement not only in balance but also in gait characteristics (9.7 ± 0.8 vs. 11.4 ± 0.2, p = 0.003). Moreover, TG also improves the psychological sphere, measured thorough MSC-(17.1 ± 0.4 vs. 16.5 ± 0.4, p = 0.034). Although an improvement in FES-I and Gait Speed can be observed, this increase does not turn out to be significant. (4) Conclusions: Results suggest how non-immersive virtual reality exergaming technology offers the opportunity to effectively train cognitive and physical domains at the same time.

An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial.

BACKGROUND: Stroke 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. METHODS: In 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov NCT04087083 . Registered on September 12, 2019.

Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.

INTRODUCTION: Deficits in balance and walking ability are relevant risk factors for falls during ageing. Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture. For this reason, the development of prevention tools and innovative rehabilitation strategies is one of the main objectives in geriatrics. Effective interventions to promote hip recovery after hip fracture are characterised by intensive and repetitive movements. One treatment approach is to increase the number of steps during the rehabilitation sessions and to improve the balance and the endurance of the patients in the use of technological devices. METHODS AND ANALYSIS: This randomised controlled trial aimed to evaluate an innovative rehabilitation treatment of elderly patients with hip fractures. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups: traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View. Assessments will be performed at baseline, at the end of treatment, at 6 months, and at 1 and 2 years after the end of the treatment. Only subjects hospitalised 4 weeks prior to the beginning of the study will be taken into consideration. Twenty treatment sessions will be conducted, divided into three training sessions per week, for 7 weeks. The technological intervention group will carry out 30 min sessions of traditional therapy and 20 min of treatment with a technological device. The control group will perform traditional therapy sessions, each lasting 50 min. The primary outcomes are risk of falling, gait performance and fear of falling. ETHICS AND DISSEMINATION: The study was approved by the Istituto di Ricerca e Cura a Carattere Scientifica, Istituto Nazionale Ricovero e Cura Anziani Ethics Committee, with identification code number 19 014. Trial results will be submitted for publication in journals and conferences. TRIAL REGISTRATION NUMBER: NCT04095338.