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2021 ◽  
Vol 11 (1) ◽  
Author(s):  
June S. Kennedy ◽  
Emily K. Reinke ◽  
Lisa G. M. Friedman ◽  
Chad Cook ◽  
Brian Forsythe ◽  
...  

Abstract Background Reverse total shoulder arthroplasty (RTSA) has emerged as a successful surgery with expanding indications. Outcomes may be influenced by post-operative rehabilitation; however, there is a dearth of research regarding optimal rehabilitation strategy following RTSA. The primary purpose of this study is to compare patient reported and clinical outcomes after RTSA in two groups: in one group rehabilitation is directed by formal, outpatient clinic-based physical therapists (PT group) as compared to a home therapy group, in which patients are instructed in their rehabilitative exercises by surgeons at post-operative appointments (HT group). Secondary aims include comparisons of complications, cost of care and quality of life between the two groups. Methods This randomised controlled trial has commenced at seven sites across the United States. Data is being collected on 200 subjects by clinical research assistants pre-operatively and post-operatively at 2, 6, and 12 weeks, 6 months, 1 and 2 year visits. The following variables are being assessed: American Shoulder and Elbow Surgeons (ASES), pain level using the numeric pain scale, the Single Assessment Numeric Evaluation (SANE) score, and shoulder active and passive range of motion for analysis of the primary aim. Chi square and t-tests will be used to measure differences in baseline characteristics of both groups. Repeated measures linear mixed effects modeling for measurement of differences will be used for outcomes associated with ASES and SANE and scores, and range of motion measures. Secondary aims will be analyzed for comparison of complications, cost, and quality of life assessment scores using data obtained from the PROMIS 29 v. 2, questionnaires administered at standard of care post-operative visits, and the electronic health record. Subjects will be allowed to crossover between the PT and HT groups, and analysis will include both intention-to-treat including patients who crossed over, and a second with cross-over patients removed, truncated to the time they crossed over. Discussion RTSA is being performed with increasing frequency, and the optimal rehabilitation strategy is unclear. This study will help clarify the role of formal physical therapy with particular consideration to outcomes, cost, and complications. In addition, this study will evaluate a proposed rehabilitation strategy. Trial registration This study is registered as NCT03719859 at ClincialTrials.gov.


Author(s):  
Giovanni Meliota ◽  
Maristella Lombardi ◽  
Marcello Benevento ◽  
Valentina Console ◽  
Marco Matteo Ciccone ◽  
...  

2021 ◽  
Vol 8 ◽  
Author(s):  
Deborah E. Linder ◽  
Sara C. Folta ◽  
Aviva Must ◽  
Christina M. Mulé ◽  
Sean B. Cash ◽  
...  

Stakeholder involvement in research has been demonstrated to increase the effectiveness, validity, and quality of a study. This paper describes the engagement of a stakeholder panel in the development and implementation of an animal-assisted intervention (AAI) assessment and program for children diagnosed with Autism Spectrum Disorder (ASD). Canines for Autism Activity and Nutrition (CAAN) aims to promote physical activity and wellness among children diagnosed with ASD by integrating activities with their pet dog during the child's ongoing Applied Behavioral Analysis (ABA) in-home therapy sessions. Feedback from stakeholders guided program development at each stage of the research process, including this publication. Utilizing a stakeholder-informed approach was essential for the development of assessment tools, program materials, and program design. Methods that may assist others to effectively partner with stakeholders to implement an AAI among children diagnosed with ASD or related disorders are described.


2021 ◽  
Vol 72 (5) ◽  
Author(s):  
Andrea PERNA ◽  
Caterina FUMO ◽  
Luca PROIETTI ◽  
Maria B. BOCCHI ◽  
Gianfranco ZIRIO ◽  
...  

Hand ◽  
2021 ◽  
pp. 155894472110527
Author(s):  
Gregory R. Toci ◽  
Anna Green ◽  
Nailah Mubin ◽  
Casey Imbergamo ◽  
Francis Sirch ◽  
...  

Background: Patient adherence is important for maximizing patient outcomes. The purpose of this randomized controlled trial was to determine patient adherence and confidence in home therapy exercises of the hand and wrist at multiple time points when distributed by either paper handout or video. Methods: Patients were prospectively enrolled and randomized in orthopedic clinics to either the handout or video exercise group. Exclusion criteria included patients less than 18 years old. Questionnaires were electronically distributed each week for 4 weeks following enrollment. Questionnaires assessed the frequency of exercise performance, percentage of exercises utilized, and confidence in performing the exercises correctly. The handout and video groups were compared via 2-sample t tests for continuous data and χ2 tests for categorical data. Results: Of the 89 patients enrolled, 71 patients responded to the initial follow-up survey (80% of randomized patients), and 54 of these patients (76%) completed all surveys at each time point. The handout group (37 patients) and the video group (34 patients) had no differences in response rate or demographics. There were no differences in frequency, exercise utilization rate, or confidence in performing exercises between groups at week 1. However, the video group reported higher exercise utilization and confidence than the handout group at subsequent time points. Conclusions: Video-format distribution of home therapy exercises is superior to that of paper handout distribution for the distal upper extremity rehabilitation. Patients in the video group utilized more exercises and had higher confidence in completing them correctly following initiation of the exercise program.


Photonics ◽  
2021 ◽  
Vol 8 (8) ◽  
pp. 303
Author(s):  
Gerhard Litscher ◽  
Laura Marinela Ailioaie

Up to now it has not yet been scientifically proven whether the technical methods of photonics in the field of photobiomodulation (PBM), photodynamic therapy (PDT), and laser acupuncture in connection with COVID-19 have achieved effective medical success. As part of this short technical note, an overview of the current scientific status is given and new equipment from our own research area is briefly presented. Although there are still many unanswered questions, it seems to be emerging that PBM and PDT in connection with the corresponding photosensitizers may make it appear worthwhile to perform experimental and clinical studies, primarily as so-called home therapy studies. In any case, the technical requirements for this are already in progress.


10.2196/26942 ◽  
2021 ◽  
Vol 6 (2) ◽  
pp. e26942
Author(s):  
Joseph Peter Salisbury

Numerous virtual reality (VR) systems have received regulatory clearance as therapeutic medical devices for in-clinic and at-home use. These systems enable remote patient monitoring of clinician-prescribed rehabilitation exercises, although most of these systems are nonimmersive. With the expanding availability of affordable and easy-to-use head-mounted display (HMD)-based VR, there is growing interest in immersive VR therapies. However, HMD-based VR presents unique risks. Following standards for medical device development, the objective of this paper is to demonstrate a risk management process for a generic immersive VR system for remote patient monitoring of at-home therapy. Regulations, standards, and guidance documents applicable to therapeutic VR design are reviewed to provide necessary background. Generic requirements for an immersive VR system for home use and remote patient monitoring are identified using predicate analysis and specified for both patients and clinicians using user stories. To analyze risk, failure modes and effects analysis, adapted for medical device risk management, is performed on the generic user stories and a set of risk control measures is proposed. Many therapeutic applications of VR would be regulated as a medical device if they were to be commercially marketed. Understanding relevant standards for design and risk management early in the development process can help expedite the availability of innovative VR therapies that are safe and effective.


2021 ◽  
pp. 100941
Author(s):  
Fredy Suter ◽  
Elena Consolaro ◽  
Stefania Pedroni ◽  
Chiara Moroni ◽  
Elena Pastò ◽  
...  

Author(s):  
Ingo Fietze ◽  
Sebastian Herberger ◽  
Gina Wewer ◽  
Holger Woehrle ◽  
Katharina Lederer ◽  
...  

Abstract Purpose Diagnosis and treatment of obstructive sleep apnea are traditionally performed in sleep laboratories with polysomnography (PSG) and are associated with significant waiting times for patients and high cost. We investigated if initiation of auto-titrating CPAP (APAP) treatment at home in patients with obstructive sleep apnea (OSA) and subsequent telemonitoring by a homecare provider would be non-inferior to in-lab management with diagnostic PSG, subsequent in-lab APAP initiation, and standard follow-up regarding compliance and disease-specific quality of life. Methods This randomized, open-label, single-center study was conducted in Germany. Screening occurred between December 2013 and November 2015. Eligible patients with moderate-to-severe OSA documented by polygraphy (PG) were randomized to home management or standard care. All patients were managed by certified sleep physicians. The home management group received APAP therapy at home, followed by telemonitoring. The control group received a diagnostic PSG, followed by therapy initiation in the sleep laboratory. The primary endpoint was therapy compliance, measured as average APAP usage after 6 months. Results The intention-to-treat population (ITT) included 224 patients (110 home therapy, 114 controls); the per-protocol population (PP) included 182 patients with 6-month device usage data (89 home therapy, 93 controls). In the PP analysis, mean APAP usage at 6 months was not different in the home therapy and control groups (4.38 ± 2.04 vs. 4.32 ± 2.28, p = 0.845). The pre-specified non-inferiority margin (NIM) of 0.3 h/day was not achieved (p = 0.130); statistical significance was achieved in a post hoc analysis when NIM was set at 0.5 h/day (p < 0.05). Time to APAP initiation was significantly shorter in the home therapy group (7.6 ± 7.2 vs. 46.1 ± 23.8 days; p < 0.0001). Conclusion Use of a home-based telemonitoring strategy for initiation of APAP in selected patients with OSA managed by sleep physicians is feasible, appears to be non-inferior to standard sleep laboratory procedures, and facilitates faster access to therapy.


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