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Dancing for Parkinson's Disease Online: Clinical Trial Process Evaluation.

ABSTRACT: Background: Dancing is an engaging physical activity for people living with Parkinson's disease (PD). We conducted a process evaluation for a PD trial on online dancing. Methods: "ParkinDANCE Online" was co-produced by people with PD, healthcare professionals, dance instructors, and a PD organisation. The evaluation mapped the following inputs: (i) stakeholder steering group to oversee program design, processes, and outcomes; (ii) co-design of online classes, based on a research evidence synthesis, expert advice, and stakeholder recommendations; (iii) trial fidelity. The key activities were (i) the co-design of classes and instruction manuals, (ii) the education of dance teachers, (iii) fidelity checking, (iv) online surveys, (v) and post-trial focus groups and interviews with participants. The outputs pertained to: (i) recruitment, (ii) retention, (iii) adverse events, (iv) fidelity, (v) protocol variations, and (vi) participant feedback. Results: Twelve people with PD, four dance instructors and two physiotherapists, participated in a 6-week online dance program. There was no attrition, nor were there any adverse events. Program fidelity was strong with few protocol variations. Classes were delivered as planned, with 100% attendance. Dancers valued skills mastery. Dance teachers found digital delivery to be engaging and practical. The safety of online testing was facilitated by careful screening and a home safety checklist. Conclusions: It is feasible to deliver online dancing to people with early PD.

SUBMITTER: Morris ME

PROVIDER: S-EPMC9957486 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Dancing for Parkinson's Disease Online: Clinical Trial Process Evaluation.

Morris Meg E ME McConvey Victor V Wittwer Joanne E JE Slade Susan C SC Blackberry Irene I Hackney Madeleine E ME Haines Simon S Brown Lydia L Collin Emma E

Healthcare (Basel, Switzerland) 20230217 4

<b>Background:</b> Dancing is an engaging physical activity for people living with Parkinson's disease (PD). We conducted a process evaluation for a PD trial on online dancing. <b>Methods:</b> "ParkinDANCE Online" was co-produced by people with PD, healthcare professionals, dance instructors, and a PD organisation. The evaluation mapped the following inputs: (i) stakeholder steering group to oversee program design, processes, and outcomes; (ii) co-design of online classes, based on a research ev ...[more]

PMID: 36833138

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Project description:Introduction: Parkinson's disease (PD) is one of the most frequent causes of disability among older people, characterized by motor disorders, rigidity, and balance problems. Recently, dance has started to be considered an effective exercise for people with PD. In particular, Irish dancing, along with tango and different forms of modern dance, may be a valid strategy to motivate people with PD to perform physical activity. The present protocol aims to implement and evaluate a rehabilitation program based on a new system called "SI-ROBOTICS," composed of multiple technological components, such as a social robotic platform embedded with an artificial vision setting, a dance-based game, environmental and wearable sensors, and an advanced AI reasoner module. Methods and Analysis: For this study, 20 patients with PD will be recruited. Sixteen therapy sessions of 50 min will be conducted (two training sessions per week, for 8 weeks), involving two patients at a time. Evaluation will be primarily focused on the acceptability of the SI-ROBOTICS system. Moreover, the analysis of the impact on the patients' functional status, gait, balance, fear of falling, cardio-respiratory performance, motor symptoms related to PD, and quality of life, will be considered as secondary outcomes. The trial will start in November 2021 and is expected to end by April 2022. Discussions: The study aims to propose and evaluate a new approach in PD rehabilitation, focused on the use of Irish dancing, together with a new technological system focused on helping the patient perform the dance steps and on collecting kinematic and performance parameters used both by the physiotherapist (for the evaluation and planning of the subsequent sessions) and by the system (to outline the levels of difficulty of the exercise). Ethics and Dissemination: The study was approved by the Ethics Committee of the IRCCS INRCA. It was recorded in ClinicalTrials.gov on the number NCT05005208. The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.

Project description:BackgroundProcess evaluations provide contextual insight into the way in which interventions are delivered. This information is essential when designing strategies to implement programs into wider clinical practice. We performed a process evaluation of the HiBalance effectiveness trial investigating the effects of a 10-week of highly challenging and progressive balance training for mild-moderate Parkinson's disease (PD). Study aims were to investigate i) the quality and quantity of intervention delivery and ii) barriers and facilitators for implementation.MethodsProcess outcomes included; Fidelity; Dose (delivered and received) Recruitment and Reach. Investigation of barriers and facilitators was guided by the Consolidated Framework for Implementation Research. Program delivery was assessed across four neurological rehabilitation sites during a two-year period. Data collection was mixed-methods in nature and quantitative and qualitative data were merged during the analysis phase.ResultsThirteen program trainers delivered the intervention to 12 separate groups during 119 training sessions. Trainer fidelity to program core components was very high in 104 (87%) of the sessions. Participant responsiveness to the core components was generally high, although adherence to the home exercise program was low (50%). No significant context-specific differences were observed across sites in terms of fidelity, dose delivered/ received or participant characteristics, despite varying recruitment methods. Facilitators to program delivery were; PD-specificity, high training frequency and professional autonomy. Perceived barriers included; cognitive impairment, absent reactional balance among participants, as well a heterogeneous group in relation to balance capacity.ConclusionThese findings provide corroborating evidence for outcome evaluation results and valuable information for the further adaptation and implementation of this program. Important lessons can also be learned for researchers and clinicians planning to implement challenging exercise training programs for people with mild-moderate PD.Trial registrationClinicalTrials.gov, NCT02727478 , registered 30 march, 2016 - Retrospectively registered.

Project description:BACKGROUND:Individuals living with Parkinson's disease (PD) can experience a range of movement disorders that affect mobility and balance and increase the risk of falls. Low health-related quality of life, depression, and anxiety are more common in people with PD than age-matched comparisons. Therapeutic dance is a form of physical activity believed to facilitate movement and therapy uptake. As well as being enjoyable, dancing is thought to improve mobility, balance, and well-being in some people living with PD. The primary objective of this study was to evaluate the feasibility and safety of a 4-week Argentine tango dance program for people with PD. METHODS:Six community dwelling individuals with mild to moderate PD were recruited from Parkinson's support groups, movement disorder clinics, and the PD association in Australia. To minimize falls risk, participants were required to be <75 years of age and physically independent (Hoehn and Yahr stages I-III). They were also required to speak English. Participants attended a 1-hour dance class at a dance studio twice per week for 4 weeks. A professional dance instructor led and choreographed the Argentine tango dance classes. Physiotherapists were present to assist participants during the class and served as dance partners as necessary. The primary outcome was feasibility, which was determined by measures of recruitment, adherence, attrition, safety (falls, near misses and adverse events), and resource requirements. Secondary measures included the Beck Depression Inventory and the Euroqol-5D, administered at baseline and post intervention. Therapy outcomes pre- and post-intervention were analyzed descriptively as medians and interquartile ranges and using Wilcoxon matched pair signed-rank tests. RESULTS:The Argentine tango dance intervention was shown to be safe, with no adverse events. Adherence to the dance program was 89%. Depression scores improved after intervention (p?=?0.04). Some challenges were associated with the need to quickly recruit participants and physiotherapists to act as dance partners during classes and to monitor participants. CONCLUSION:The 4-week, twice weekly Argentine tango dancing program was shown to be feasible and safe for people with mild-to-moderately severe PD.

Project description:BackgroundUbiquitous digital technologies such as smartphone sensors promise to fundamentally change biomedical research and treatment monitoring in neurological diseases such as PD, creating a new domain of digital biomarkers.ObjectivesThe present study assessed the feasibility, reliability, and validity of smartphone-based digital biomarkers of PD in a clinical trial setting.MethodsDuring a 6-month, phase 1b clinical trial with 44 Parkinson participants, and an independent, 45-day study in 35 age-matched healthy controls, participants completed six daily motor active tests (sustained phonation, rest tremor, postural tremor, finger-tapping, balance, and gait), then carried the smartphone during the day (passive monitoring), enabling assessment of, for example, time spent walking and sit-to-stand transitions by gyroscopic and accelerometer data.ResultsAdherence was acceptable: Patients completed active testing on average 3.5 of 7 times/week. Sensor-based features showed moderate-to-excellent test-retest reliability (average intraclass correlation coefficient = 0.84). All active and passive features significantly differentiated PD from controls with P < 0.005. All active test features except sustained phonation were significantly related to corresponding International Parkinson and Movement Disorder Society-Sponsored UPRDS clinical severity ratings. On passive monitoring, time spent walking had a significant (P = 0.005) relationship with average postural instability and gait disturbance scores. Of note, for all smartphone active and passive features except postural tremor, the monitoring procedure detected abnormalities even in those Parkinson participants scored as having no signs in the corresponding International Parkinson and Movement Disorder Society-Sponsored UPRDS items at the site visit.ConclusionsThese findings demonstrate the feasibility of smartphone-based digital biomarkers and indicate that smartphone-sensor technologies provide reliable, valid, clinically meaningful, and highly sensitive phenotypic data in Parkinson's disease. © 2018 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Project description:Conventional dissemination of clinical trial results has inconsistent impact on physician practices. A more comprehensive plan to influence determinants of prescribing practices is warranted.To report the response from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial to the National Heart, Lung, and Blood Institute's requirement for dissemination and evaluation of trials with potential immediate public health applicability.ALLHAT's dissemination plan had two-components: (1) a traditional approach of media coverage, scientific presentation, and publication; and (2) a theory-based approach targeting determinants of clinician behavior. Strategies included: (1) academic detailing, in which physicians approach colleagues regarding blood pressure management, (2) direct patient messages to stimulate communication with physicians regarding blood pressure control, (3) approaches to formulary systems to use educational and economic incentives for evidence-based prescription, and (4) direct professional organization appeals to clinicians.One hundred and forty-seven Investigator Educators reported 1698 presentations to 18,524 clinicians in 41 states and the District of Columbia. The pre- and post-test responses of 1709 clinicians in the face-to-face meetings indicated significant changes in expectations for positive patient outcomes and intention to prescribe diuretics. Information was mailed to 55 individuals representing 20 professional organizations and to eight formulary systems. Direct-to-patient messages were provided to 14 sites that host patient newsletters and Web sites such as health plans and insurance companies, 62 print mass media outlets, and 12 broadcast media sites.It was not within the scope of the project to conduct a randomized trial of the impact of the dissemination. However, impact evaluation using quasi-experimental designs is ongoing.A large multi-method dissemination of clinical trial results is feasible. Planning for dissemination efforts, including evaluation research, should be considered as a part of the funding and design of the clinical trial and should begin early in trial planning.

Project description:BackgroundThe PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why.Methods/designDrawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined.DiscussionTo date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why.Trial registrationISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

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Dancing for Parkinson's Disease Online: Clinical Trial Process Evaluation.

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Dancing for Parkinson's Disease Online: Clinical Trial Process Evaluation.

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