Feasibility and preliminary efficacy of a telerehabilitation approach to group adapted tango instruction for people with Parkinson disease

2016 ◽  
Vol 23 (8) ◽  
pp. 740-746 ◽  
Author(s):  
Katie J Seidler ◽  
Ryan P Duncan ◽  
Marie E McNeely ◽  
Madeleine E Hackney ◽  
Gammon M Earhart
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Parkinson Disease ◽  
A Priori ◽  
Significant Group ◽  
Time Effects ◽  
Group Time ◽  
Participant Retention ◽  
Outcome Differences ◽  
Over Time

People with Parkinson disease (PD) demonstrate improvements in motor function following group tango classes, but report long commutes as a barrier to participation. To increase access, we investigated a telerehabilitation approach to group tango instruction. Twenty-six people with mild-to-moderate PD were assigned based on commute distance to either the telerehabilitation group (Telerehab) or an in-person instruction group (In-person). Both groups followed the same twice-weekly, 12-week curriculum with the same instructor. Feasibility metrics were participant retention, attendance and adverse events. Outcomes assessed were balance, PD motor sign severity and gait. Participant retention was 85% in both groups. Attendance was 87% in the Telerehab group and 84% in the In-person group. No adverse events occurred. Balance and motor sign severity improved significantly over time ( p < 0.001) in both groups, with no significant group × time effects. Gait did not significantly change. Since a priori feasibility criteria were met or exceeded, and there were no notable outcome differences between the two instruction approaches, this pilot study suggests a telerehabilitation approach to group tango class for people with PD is feasible and may have similar outcomes to in-person instruction.

scholarly journals A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy

10.2196/18985 ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. e18985
Author(s):  
Merrill R Landers ◽  
Terry D Ellis
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Parkinson Disease ◽  
Exercise Program ◽  
Mobile App ◽  
Medical Attention ◽  
Timed Up And Go ◽  
Serious Adverse Events ◽  
Primary Endpoints ◽  
Single Cohort

Background Many people with Parkinson disease do not have access to exercise programs that are specifically tailored to their needs and capabilities. This mobile app allows people with Parkinson disease to access Parkinson disease–specific exercises that are individually tailored using in-app demographic questions and performance tests which are fed into an algorithm which in turn produces a video-guided exercise program. Objective To test the feasibility, safety, and signal of efficacy of a mobile app that facilitates exercise for people with Parkinson disease. Methods A prospective, single-cohort design of people with Parkinson disease who had downloaded the 9zest app for exercise was used for this 12-week pilot study. Participants, who were recruited online, were encouraged to exercise with the full automated app for ≥150 minutes each week. The primary endpoints were feasibility (app usage and usability questions) and safety (adverse events and falls). The primary endpoints for signal of efficacy were a comparison of the in-app baseline and 8-week outcomes on the 30-second Sit-To-Stand (STS) test, Timed Up and Go (TUG) test, and the Parkinson’s Disease Questionnaire 8 (PDQ8). Results For feasibility, of the 28 participants that completed the study, 12 participants averaged >150 minutes of app usage per week (3 averaged 120-150, 4 averaged 90-120, and 9 averaged less than 90 minutes). A majority of participants (>74%) felt the exercise was of value (16/19; 9 nonrespondents), provided adequate instruction (14/19; 9 nonrespondents), and was appropriate for level of function (16/19; 9 nonrespondents). For safety, there were no serious adverse events that occurred during the app-guided exercise. There were 4 reports of strain/sprain injuries while using the app among 3 participants, none of which necessitated medical attention. For signal of efficacy, there was improvement for each of the primary endpoints: STS (P=.01), TUG (P<.001), and PDQ8 (P=.01). Conclusions Independent, video-guided exercise using a mobile app designed for exercise in Parkinson disease was safe and feasible though there was variability in app usage. Despite this, the results provide evidence for a signal of efficacy as there were improvements in 3 of the 3 outcomes. Trial Registration ClinicalTrials.gov NCT03459586; https://clinicaltrials.gov/ct2/show/NCT03459586

scholarly journals A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy (Preprint)

2020 ◽  
Author(s):  
Merrill R Landers ◽  
Terry D Ellis
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Parkinson Disease ◽  
Exercise Program ◽  
Mobile App ◽  
Medical Attention ◽  
Timed Up And Go ◽  
Serious Adverse Events ◽  
Primary Endpoints ◽  
Single Cohort

BACKGROUND Many people with Parkinson disease do not have access to exercise programs that are specifically tailored to their needs and capabilities. This mobile app allows people with Parkinson disease to access Parkinson disease–specific exercises that are individually tailored using in-app demographic questions and performance tests which are fed into an algorithm which in turn produces a video-guided exercise program. OBJECTIVE To test the feasibility, safety, and signal of efficacy of a mobile app that facilitates exercise for people with Parkinson disease. METHODS A prospective, single-cohort design of people with Parkinson disease who had downloaded the 9zest app for exercise was used for this 12-week pilot study. Participants, who were recruited online, were encouraged to exercise with the full automated app for ≥150 minutes each week. The primary endpoints were feasibility (app usage and usability questions) and safety (adverse events and falls). The primary endpoints for signal of efficacy were a comparison of the in-app baseline and 8-week outcomes on the 30-second Sit-To-Stand (STS) test, Timed Up and Go (TUG) test, and the Parkinson’s Disease Questionnaire 8 (PDQ8). RESULTS For feasibility, of the 28 participants that completed the study, 12 participants averaged &gt;150 minutes of app usage per week (3 averaged 120-150, 4 averaged 90-120, and 9 averaged less than 90 minutes). A majority of participants (&gt;74%) felt the exercise was of value (16/19; 9 nonrespondents), provided adequate instruction (14/19; 9 nonrespondents), and was appropriate for level of function (16/19; 9 nonrespondents). For safety, there were no serious adverse events that occurred during the app-guided exercise. There were 4 reports of strain/sprain injuries while using the app among 3 participants, none of which necessitated medical attention. For signal of efficacy, there was improvement for each of the primary endpoints: STS (<i>P</i>=.01), TUG (<i>P</i>&lt;.001), and PDQ8 (<i>P</i>=.01). CONCLUSIONS Independent, video-guided exercise using a mobile app designed for exercise in Parkinson disease was safe and feasible though there was variability in app usage. Despite this, the results provide evidence for a signal of efficacy as there were improvements in 3 of the 3 outcomes. CLINICALTRIAL ClinicalTrials.gov NCT03459586; https://clinicaltrials.gov/ct2/show/NCT03459586

Kategorisierung der Schädelform des Cavalier King Charles Spaniels

2019 ◽  
Vol 47 (02) ◽  
pp. 133-133
Keyword(s):  
Pilot Study ◽  
Cavalier King Charles Spaniel ◽  
Conformation Changes ◽  
Veterinary Record ◽  
Changes Over Time ◽  
Over Time

Knowler SP, Gillstedt L, Mitchell TJ et al. Pilot study of head conformation changes over time in the Cavalier King Charles spaniel breed. Veterinary Record 2019. doi:10.1136/vr.105135.

Safety of Vinflunine in Patients with Advanced Urothelial Carcinoma Refractory to Platinum-based Chemotherapy: A Prospective Pilot Study

2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Transitional Cell ◽  
Chemotherapeutic Agents ◽  
Serious Adverse Events ◽  
Platinum Based Chemotherapy ◽  
Number Of Patients ◽  
Advanced Urothelial Carcinoma ◽  
Grade 3

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.

scholarly journals Robust Inferences from a Before-and-After Study with Multiple Unaffected Control Groups

2013 ◽  
Vol 1 (2) ◽  
pp. 209-234 ◽  
Author(s):  
Pengyuan Wang ◽  
Mikhail Traskin ◽  
Dylan S. Small
Keyword(s):  
Sensitivity Analysis ◽  
Control Groups ◽  
Two Stage ◽  
Time Effects ◽  
Unaffected Control ◽  
Group Time ◽  
Before And After ◽  
Group Variation ◽  
The Impact ◽  
Before And After Study

AbstractThe before-and-after study with multiple unaffected control groups is widely applied to study treatment effects. The current methods usually assume that the control groups’ differences between the before and after periods, i.e. the group time effects, follow a normal distribution. However, there is usually no strong a priori evidence for the normality assumption, and there are not enough control groups to check the assumption. We propose to use a flexible skew-t distribution family to model group time effects, and consider a range of plausible skew-t distributions. Based on the skew-t distribution assumption, we propose a robust-t method to guarantee nominal significance level under a wide range of skew-t distributions, and hence make the inference robust to misspecification of the distribution of group time effects. We also propose a two-stage approach, which has lower power compared to the robust-t method, but provides an opportunity to conduct sensitivity analysis. Hence, the overall method of analysis is to use the robust-t method to test for the overall hypothesized range of shapes of group variation; if the test fails to reject, use the two-stage method to conduct a sensitivity analysis to see if there is a subset of group variation parameters for which we can be confident that there is a treatment effect. We apply the proposed methods to two datasets. One dataset is from the Current Population Survey (CPS) to study the impact of the Mariel Boatlift on Miami unemployment rates between 1979 and 1982.The other dataset contains the student enrollment and grade repeating data in West Germany in the 1960s with which we study the impact of the short school year in 1966–1967 on grade repeating rates.

scholarly journals P34 Characteristics, diagnosis and management of Cushing’s disease - A systematic review and meta-analysis

BJS Open ◽  
2021 ◽  
Vol 5 (Supplement_1) ◽  
Author(s):  
Chan Hee Koh ◽  
Danyal Z Khan ◽  
Ronneil Digpal ◽  
Hugo Layard Horsfall ◽  
Hani J Marcus ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Cushing’S Disease ◽  
Meta Analysis ◽  
A Priori ◽  
Pituitary Surgery ◽  
Serum Cortisol ◽  
Cushing's Disease ◽  
Diagnosis And Management ◽  
Over Time

Abstract Introduction The clinical practice and research in the diagnosis and management of Cushing’s disease remains heterogeneous and challenging to this day. We sought to establish the characteristics of Cushing’s disease, and the trends in diagnosis, management and reporting in this field. Methods Searches of PubMed and Embase were conducted. Study protocol was registered a-priori. Random-effects analyses were conducted to establish numerical estimates. Results Our screening returned 159 papers. The average age of adult patients with Cushing’s disease was 39.3, and 13.6 for children. The male:female ratio was 1:3. 8% of patients had undergone previous transsphenoidal resection. The ratio of macroadenomas: microadenomas:imaging-undetectable adenomas was 18:53:29. The most commonly reported preoperative biochemical investigations were serum cortisol (average 26.4µg/dL) and ACTH (77.5pg/dL). Postoperative cortisol was most frequently used to define remission (74.8%), most commonly with threshold of 5µg/dL (44.8%). Average remission rates were 77.8% with recurrence rate of 13.9%. Median follow-up was 38 months. Majority of papers reported age (81.9%) and sex (79.4%). Only 56.6% reported whether their patients had previous pituitary surgery. 45.3% reported whether their adenomas were macroadenoma, microadenoma or undetectable. Only 24.1% reported preoperative cortisol, and this did not improve over time. 60.4% reported numerical thresholds for cortisol in defining remission, and this improved significantly over time (p = 0.004). Visual inspection of bubbleplots showed increasing preference for threshold of 5µg/dL. 70.4% reported the length of follow up. Conclusion We quantified the characteristics of Cushing’s disease, and analysed the trends in investigation and reporting. This review may help to inform future efforts in forming guidelines for research and clinical practice.

scholarly journals Global Trigger Tool methodology to detect adverse events: pilot study at Academic Hospital of Udine

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
E Scarpis ◽  
S Degan ◽  
D De Corti ◽  
F Mellace ◽  
R Cocconi ◽  
...  
Keyword(s):  
Patient Safety ◽  
Adverse Events ◽  
Academic Hospital ◽  
Trigger Tool ◽  
Hospital Acquired Infections ◽  
Frequent Type ◽  
Global Trigger Tool ◽  
Clinical Records ◽  
Hospital Acquired ◽  
Over Time

Abstract Introduction Identification and measurement of adverse events (AEs) is crucial for patient safety in order to monitor them over time and to implement quality improvement programs, testing if they are effective. Global Trigger Tool (GTT) has been proposed as a low-cost method, being also the most effective to detect AEs. This study aims to describe the number of triggers, the rate and level of AEs identified by GTT and the most frequent type of AE. Methods The Italian version of the GTT was used. Ten paper-based clinical records (CRs) randomly selected every 2 weeks were reviewed from January to April 2019 by three independent reviewers (two nurses, one doctor) at the Academic Hospital of Udine. The AEs rates calculated are: AEs per 1,000 patient-days, AEs per 100 admissions, percentage of admissions with an AE. AEs were classified by harm levels according to National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). Results CRs reviewed were 80. Mean age of the patients was 69.3±16.4, women were 37.5%. Mean hospitalisation was 16.8±15.3. Nine were the cases of re-hospitalisation within 30 days (11.3%). The total number of trigger was 156. AEs were 31, with at least one AE on 27.5% of admissions, 38.8 AEs per 100 admissions and 23 AEs per 1,000 patient-days. AEs with harm level E, F and H were respectively 5 (16.1%), 24 (77.4%) and 2 (6.5%). The most frequent type of AE were hospital acquired infections with 15 cases (48.4%). Conclusions The most frequent type of AE was the hospital acquired infections. Rates and levels of AEs were higher than other international studies, probably because of the limited number of CRs reviewed. Key messages Global Trigger Tool is an effective method to detect adverse patient safety events in order to monitor them over time. The most frequent type of adverse events was the hospital acquired infections.

scholarly journals The Use of the Oxygenated AirdriveTM Machine Perfusion System in Kidney Graft Preservation: A Clinical Pilot Study

2020 ◽  
Vol 61 (6) ◽  
pp. 153-162
Author(s):  
Julia H.E. Houtzager ◽  
Sebastiaan David Hemelrijk ◽  
Ivo C.J.H. Post ◽  
Mirza M Idu ◽  
Frederike J. Bemelman ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
Pilot Study ◽  
Adverse Events ◽  
Deceased Donor ◽  
Kidney Graft ◽  
Machine Perfusion ◽  
End Points ◽  
Viable Solution ◽  
Technical Failures

Background: The shortage of donor kidneys has led to the use of marginal donors, e.g., those whose kidneys are donated after circulatory death. Preservation of the graft by hypothermic machine perfusion (HMP) provides a viable solution to reduce warm ischemic damage. This pilot study was undertaken to assess the feasibility and patient safety of the AirdriveTM HMP system in clinical kidney transplantation. Methods: Five deceased-donor kidneys were preserved using the oxygenated Airdrive HMP system between arrival at the recipient center (Amsterdam UMC) and implantation in the patient. The main study end-points were adverse effects due to the use of Airdrive HMP. Secondary end-points were clinical outcomes and perfusion parameters. All events occurring during the transplantation procedure or within 1 month of follow-up were monitored. Results: Five patients were included in this pilot study. No technical failures were observed during the preservation period using the Airdrive HMP. Mean perfusion parameters were: duration 8.5 h (3–15 h), pressure 25 mm Hg (18–25 mm Hg), flow 49.77 mL/min (19–58 mL/min), resistance 0.57 mm Hg/min/mL (0.34–1.3 mm Hg/min/mL), and temperature 8.2 °C (2–13°C). Mean cold ischemia time (CIT) was 20.2 h (11–29.5 h). No adverse events or technical failures were observed during preservation and transplantation or during the 1-month follow-up. Conclusions: This pilot study showed the feasibility of the use of the Airdrive HMP system with no adverse events in clinical kidney transplantation.

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