Pilot and Feasibility Studies in Rehabilitation: Moving into the Next Decade
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ABSTRACT:
SUBMITTER: Kho M
PROVIDER: S-EPMC8781489 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:In a time of rapid advances in science and technology, the opportunities for radiation oncology are undergoing transformational change. The linkage between and understanding of the physical dose and induced biological perturbations are opening entirely new areas of application. The ability to define anatomic extent of disease and the elucidation of the biology of metastases has brought a key role for radiation oncology for treating metastatic disease. That radiation can stimulate and suppress subpopulations of the immune response makes radiation a key participant in cancer immunotherapy. Targeted radiopharmaceutical therapy delivers radiation systemically with radionuclides and carrier molecules selected for their physical, chemical, and biochemical properties. Radiation oncology usage of "big data" and machine learning and artificial intelligence adds the opportunity to markedly change the workflow for clinical practice while physically targeting and adapting radiation fields in real time. Future precision targeting requires multidimensional understanding of the imaging, underlying biology, and anatomical relationship among tissues for radiation as spatial and temporal "focused biology." Other means of energy delivery are available as are agents that can be activated by radiation with increasing ability to target treatments. With broad applicability of radiation in cancer treatment, radiation therapy is a necessity for effective cancer care, opening a career path for global health serving the medically underserved in geographically isolated populations as a substantial societal contribution addressing health disparities. Understanding risk and mitigation of radiation injury make it an important discipline for and beyond cancer care including energy policy, space exploration, national security, and global partnerships.
| S-EPMC8328099 | biostudies-literature
Project description:With continuously increasing costs of conducting trials, use of innovative approaches-such as pragmatic trials, registry-based randomised trials, adaptive trials, personalised medicine trials, platform trials, and basket trials-to the design and conduct of clinical trials has been advocated as one of the most promising solutions. In this editorial, we propose that the next wave of feasibility or pilot studies should focus on assessing the feasibility of trials using these designs, which we see as an imperative in order to unleash their potential to reduce trial costs and accelerate the drug development process and the search for best treatments, so that the right treatments can be delivered as soon as possible to the right patients.
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| S-EPMC10998328 | biostudies-literature
Project description:Physical rehabilitation is frequently recommended in dogs recovering from acute thoracolumbar intervertebral disc extrusion (TL-IVDE), but protocols vary widely. The objective of this study was to evaluate the feasibility of incorporating sensory-integrated neurorehabilitation strategies into a post-operative rehabilitation protocol in dogs with TL-IVDE. Non-ambulatory dogs with acute TL-IVDE managed surgically were prospectively recruited to this unblinded cross-over feasibility study. Eligible dogs were randomized to start with tactile-enhanced (artificial grass) or auditory-enhanced (floor piano) basic rehabilitation exercises performed twice daily for the first 4 weeks before switching to the opposite surface for the subsequent 4 weeks. Neurologic examination, open field gait scoring, girth measurements and an owner-completed feasibility questionnaire were performed at baseline and 2, 4, 6, and 8 weeks post-operatively. Twenty-four dogs were enrolled, 12 randomized to each order of exercises. Gait scores did not differ between the two groups at baseline, 4 or 8 week visits. All modified exercises could be performed and compliance was high. Adverse events potentially attributable to the study surface were mild, self-limiting and occurred in 2/24 dogs. The most common surface-related limitations were that the piano was slippery and that both surfaces were too short. The artificial grass was preferred by owners and dogs compared to the floor piano surface, but this was influenced by which surface was utilized first. Auditory and tactile modifications were feasible and safe to incorporate into a standardized rehabilitation protocol. This pilot study could prompt larger efficacy studies investigating the benefit of sensory-integrated rehabilitation in dogs with TL-IVDE.
| S-EPMC9237616 | biostudies-literature
Project description:BackgroundThe feasibility of cognitive rehabilitation is rarely investigated in patients with advanced multiple sclerosis.MethodsEighteen patients with advanced multiple sclerosis (median EDSS = 7.5) were randomized into restorative or compensatory cognitive rehabilitation. Feasibility was determined by adherence rate, completion rate, patient satisfaction, self-reported fatigue, training difficulty, and training duration.ResultsAdherence rates and completion rates were over 70%, and patients were highly satisfied in both groups. Energy levels decreased minimally during the sessions (pre = 6.9 vs post = 6.4). Training difficulty (4.6) and duration (5.7) were close to ideal (scale 1-10, 5 = ideal).ConclusionsCognitive rehabilitation, with minor adjustments, appears feasible in patients with advanced multiple sclerosis.
| S-EPMC8669124 | biostudies-literature
Project description:Objective: This article describes the findings of a study examining the ability of persons with strokes to use home virtual rehabilitation system (HoVRS), a home-based rehabilitation system, and the impact of motivational enhancement techniques on subjects' motivation, adherence, and motor function improvements subsequent to a 3-month training program. Materials and Methods: HoVRS integrates a Leap Motion controller, a passive arm support, and a suite of custom-designed hand rehabilitation simulations. For this study, we developed a library of three simulations, which include activities such as flexing and extending fingers to move a car, flying a plane with wrist movement, and controlling an avatar running in a maze using reaching movements. Two groups of subjects, the enhanced motivation (EM) group and the unenhanced control (UC) group, used the system for 12 weeks in their homes. The EM group trained using three simulations that provided 8-12 levels of difficulty and complexity. Graphics and scoring opportunities increased at each new level. The UC group performed the same simulations, but difficulty was increased utilizing an algorithm that increased difficulty incrementally, making adjustments imperceptible. Results: Adherence to both the EM and UC protocols exceeded adherence to home exercise programs described in the stroke rehabilitation literature. Both groups demonstrated improvements in upper extremity function. Intrinsic motivation levels were better for the EM group and motivation levels were maintained for the 12-week protocol. Conclusion: A 12-week home-based training program using HoVRS was feasible. Motivational enhancement may have a positive impact on motivation, adherence, and motor outcome.
| S-EPMC7133442 | biostudies-literature
Project description:PurposeNew anticancer agents that target a single cell surface receptor, up-regulated or amplified gene product, or mutated gene, have met with some success in treating advanced cancers. However, patients' tumors still eventually progress on these therapies. If it were possible to identify a larger number of targetable vulnerabilities in an individual's tumor, multiple targets could be exploited with the use of specific therapeutic agents, thus possibly giving the patient viable therapeutic alternatives.Experimental designIn this exploratory study, we used next-generation sequencing technologies (NGS) including whole genome sequencing (WGS), and where feasible, whole transcriptome sequencing (WTS) to identify genomic events and associated expression changes in advanced cancer patients.ResultsWGS on paired tumor and normal samples from nine advanced cancer patients and WTS on six of these patients' tumors was completed. One patient's treatment was based on targets and pathways identified by NGS and the patient had a short-lived PET/CT response with a significant reduction in his tumor-related pain. To design treatment plans based on information garnered from NGS, several challenges were encountered: NGS reporting delays, communication of results to out-of-state participants and their treating oncologists, and chain of custody handling for fresh biopsy samples for Clinical Laboratory Improvement Amendments (CLIA) target validation.ConclusionWhile the initial effort was a slower process than anticipated due to a variety of issues, we demonstrate the feasibility of using NGS in advanced cancer patients so that treatments for patients with progressing tumors may be improved.
| S-EPMC3813699 | biostudies-literature
Project description:BackgroundImplementation trials aim to test the effects of implementation strategies on the adoption, integration or uptake of an evidence-based intervention within organisations or settings. Feasibility and pilot studies can assist with building and testing effective implementation strategies by helping to address uncertainties around design and methods, assessing potential implementation strategy effects and identifying potential causal mechanisms. This paper aims to provide broad guidance for the conduct of feasibility and pilot studies for implementation trials.MethodsWe convened a group with a mutual interest in the use of feasibility and pilot trials in implementation science including implementation and behavioural science experts and public health researchers. We conducted a literature review to identify existing recommendations for feasibility and pilot studies, as well as publications describing formative processes for implementation trials. In the absence of previous explicit guidance for the conduct of feasibility or pilot implementation trials specifically, we used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as a framework for conceptualising the application of feasibility and pilot testing of implementation interventions. We discuss and offer guidance regarding the aims, methods, design, measures, progression criteria and reporting for implementation feasibility and pilot studies.ConclusionsThis paper provides a resource for those undertaking preliminary work to enrich and inform larger scale implementation trials.
| S-EPMC7603668 | biostudies-literature
Project description:Objective: The aim of this pilot randomized clinical trial was to test the feasibility and efficacy of an exergame-based cognitive-motor training program in geriatric inpatients. Methods: The study participants were randomly allocated to either the exergame intervention group or the control group. The control group received the standard rehabilitation treatment offered in the clinic. In addition to the standard rehabilitation program, the intervention group conducted supervised exergame training on 5 days per week using the Dividat Senso, an exergame system specifically designed for older adults. The primary outcome was feasibility, as measured by e.g., adherence rate, attrition rate, occurrence of adverse events, System Usability Scale (SUS) and NASA-TLX score. Secondary outcomes included measures of physical and cognitive functioning such as comfortable walking speed, maximal walking speed, dual task walking speed, Short Physical Performance Battery (SPPB), Timed Up and Go test (TUG), Color-Word Interference test (D-KEFS), Trail Making test A and B (TMT), Go/No-Go test and Step Reaction Time test (SRTT). All secondary outcome measures were assessed pre- and post-intervention. Results: Thirty-nine persons were included in the study. Average adherence rate was 99%, there were no intervention-related dropouts and no adverse events. The mean System Usability Scale (SUS) score was 83.6 and the mean NASA-TLX score 45.5. Significant time-group interaction effects were found for the dual task walking speed, the Go/No-Go test and Step Reaction Time test (SRTT). Conclusion: Exergaming is a feasible, safe and effective cognitive-motor training approach in inpatient rehabilitation of geriatric patients. Incorporating exergaming in the rehabilitation program of geriatric patients offers potential to reduce fall risk factors and to increase patients' exercise motivation and rehabilitation success.
| S-EPMC8667343 | biostudies-literature
Project description:BackgroundSurvivors of stroke are often deconditioned and have limited opportunities for exercise post-rehabilitation. Cardiac Rehabilitation (CR), a structured exercise program offered post-cardiac event in the United States (U.S.), may provide an opportunity for continued exercise. The purpose of this study was to examine the feasibility of integrating survivors of stroke into an existing, hospital-based CR program through an assessment of (1) recruitment, uptake and retention, (2) adherence and fidelity, (3) acceptability and (4) safety.MethodsA mixed methods design combined a single group, pre-post design, pilot feasibility study with an imbedded qualitative inquiry. Survivors of stroke were recruited into a standard 12-week, 36 visit CR program.ResultsFifty-three survivors were referred, 29 started and 24 completed the program. Program uptake rate was 55% and completion rate was 83%. Eleven completers and one non-completer participated in the qualitative interviews. Program completers attended an average of 25.25 (SD 5.82) sessions with an average of 38.93 (SD 5.64) exercise minutes per session while reaching targeted rate of perceived exertion levels. Qualitative themes included perceived benefits of an individualized program in a group setting, positive interactions with qualified staff, opportunities for socialization, and regular monitoring and staff attentiveness promoting feelings of safety.ConclusionsSurvivors of stroke were able to meet Medicare standard dosage (frequency and session duration) and rate of perceived intensity goals, and perceived the program as needed regardless of their mobility limitations or previous exercise experience. Primary challenges included managing referrals and uptake. Results support feasibility and benefit for survivors to integrate into U.S. CR programs.
| S-EPMC8007047 | biostudies-literature