Trial Summary
What is the purpose of this trial?The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder Rating Scale in patients with functional tremor. The main questions the study aims to answer are:
1. Is the Tremor Retrainer application usable for patients and are there signs that it can help functional tremor?
2. Can a televideo administration of the Simplified Functional Movement Disorder Rating Scale give enough information to use this scale via televideo in future studies?
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Tremor Retrainer App treatment for tremors?
Research shows that smartphone applications can effectively measure and assess tremors, as they provide objective and quantitative evaluations similar to clinical tools. These apps have been used successfully in Parkinson's disease to assess tremor, suggesting potential for similar effectiveness in other tremor-related conditions.
12345Is the Tremor Retrainer App safe for use in humans?
The available research on mobile applications for tremor assessment, particularly in Parkinson's disease, suggests that these apps are generally safe to use, as they have been validated against clinical scales and laboratory equipment. However, specific safety validation studies for the Tremor Retrainer App itself are not mentioned.
12456How is the Tremor Retrainer App treatment different from other treatments for tremors?
The Tremor Retrainer App is unique because it uses a smartphone application to assess and potentially retrain tremors, leveraging the phone's built-in sensors like accelerometers and gyroscopes. This approach offers a more accessible, cost-effective, and objective way to evaluate and manage tremors compared to traditional methods that often require expensive and bulky equipment.
14578Eligibility Criteria
This trial is for individuals with functional tremor and related conditions like hysteria, movement disorders, or conversion disorder. Participants should be able to use a smartphone application designed to help manage their tremor.Inclusion Criteria
I understand and can follow the study's procedures.
I am 10 years old or older.
Informed consent obtained and signed
+3 more
Exclusion Criteria
Cognitive impairment with previously diagnosed intellectual disability (IQ<70) or dementia
New treatment planned to begin before study visit 3
Hearing impairment not addressed by hearing aids
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (televideo)
Observation
Participants undergo a one-week observation period before starting the intervention
1 week
Treatment
Participants complete the one-week four-hour Tremor Retrainer smartphone protocol
1 week
4 visits (in-person), 1 visit (televideo)
Follow-up
Participants are monitored for changes in tremor severity and usability of the application
3-4 months
4 visits (in-person)
Participant Groups
The study tests the Tremor Retrainer app's usability and effectiveness in managing functional tremors. It also evaluates if the Simplified Functional Movement Disorder Rating Scale can be reliably used through televideo for future research.
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
All subjects will receive intervention with Tremor Retrainer smartphone application
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
Child Neurology FoundationCollaborator
References
Mobile Applications for Resting Tremor Assessment in Parkinson's Disease: A Systematic Review. [2023](1) Background: Resting tremor is a motor manifestation present in most Parkinson's disease (PD) patients. For its assessment, several scales have been created, but mobile applications could help in objectively assessing resting tremor in PD patients in person and/or remotely in a more ecological scenario. (2) Methods: a systematic review following the PRISMA recommendations was conducted in scientific databases (PubMed, Medline, Science Direct, Academic Search Premier, and Web of Science) and in the main mobile application markets (Google Play, iOS App Store, and Windows Store) to determine the applications available for the assessment of resting tremor in patients with PD using only the measurement components of the phone itself (accelerometers and gyroscopes). (3) Results: 14 articles that used mobile apps to assess resting tremor in PD were included, and 13 apps were identified in the mobile application markets for the same purpose. The risk of bias and of applicability concerns of the articles analyzed was low. Mobile applications found in the app markets met an average of 85.09% of the recommendations for the development of medical mobile applications. (4) Conclusions: the use of mobile applications for the evaluation of resting tremor in PD patients has great potential, but validation studies for this purpose are scarce.
Usability of a daily mHealth application designed to address mobility, speech and dexterity in Parkinson's disease. [2020]Aim: This study investigated the usability of a mobile health (mHealth) smartphone application to treat gait, speech and dexterity in people with Parkinson's disease. Methods: Participants either used an mHealth application (intervention) or maintained their normal routine (control) for 12 weeks and were evaluated at baseline and post-test time points for primary outcome measures of adherence, gait, speech and dexterity. mHealth application adherence was compared with percent change scores on gait, speech and dexterity measures. Results: Adherence was moderate and there were no significant group, time or interaction effects for any outcome measures. Correlations between adherence and outcomes were weak and negative. Conclusion: These data suggest that usability of this mHealth application was limited as indicated by low adherence. The application alone in its present form was not adequate to treat symptoms of gait, speech or dexterity in people with Parkinson's disease.
A Smartphone-Based Tool for Assessing Parkinsonian Hand Tremor. [2016]The aim of this study is to propose a practical smartphone-based tool to accurately assess upper limb tremor in Parkinson's disease (PD) patients. The tool uses signals from the phone's accelerometer and gyroscope (as the phone is held or mounted on a subject's hand) to compute a set of metrics which can be used to quantify a patient's tremor symptoms. In a small-scale clinical study with 25 PD patients and 20 age-matched healthy volunteers, we combined our metrics with machine learning techniques to correctly classify 82% of the patients and 90% of the healthy volunteers, which is high compared to similar studies. The proposed method could be effective in assisting physicians in the clinic, or to remotely evaluate the patient's condition and communicate the results to the physician. Our tool is low cost, platform independent, noninvasive, and requires no expertise to use. It is also well matched to the standard clinical examination for PD and can keep the patient "connected" to his physician on a daily basis. Finally, it can facilitate the creation of anonymous profiles for PD patients, aiding further research on the effectiveness of medication or other overlooked aspects of patients' lives.
Measuring tremor with a smartphone. [2022]Tremor is the most common movement disorder. However; characterizing it in large populations is not easily accomplished since current methodologies are not adapted to large-scale field studies. To overcome this challenge, a smartphone application was developed as a stand-alone platform to assess tremor. The current book chapter details the steps taken to validate this mobile application. Data recorded with the smartphone was analyzed online and offline as well as compared to laboratory equipment and a clinical scale. This allowed for the identification of the tremor properties that could reliably be characterized with the smartphone as well as the limits of the hardware. It also allowed for the identification of tasks that could be performed with the smartphone when tremor was being assessed. Finally, we confirmed the clinical relevance of the results provided by the smartphone application.
TREMOR12: An Open-Source Mobile App for Tremor Quantification. [2018]Evaluating the effect of treatment of tremor is mostly performed with clinical rating scales. Mobile applications facilitate a more rapid, objective, and quantitative evaluation of treatment effect. Existing mobile apps do not offer raw data access, which limits algorithm development.
Developing a Tool for Remote Digital Assessment of Parkinson's Disease. [2022]The natural fluctuation of motor symptoms of Parkinson's disease (PD) makes judgement of any change challenging and the use of clinical scales such as the International Parkinson and Movement Disorder Society (MDS)-UPDRS imperative. Recently developed commodity mobile communication devices, such as smartphones, could possibly be used to assess motor symptoms in PD patients in a convenient way with low cost. We provide the first report on the development and testing of stand-alone software for mobile devices that could be used to assess both tremor and bradykinesia of PD patients.
Using the Accelerometers Integrated in Smartphones to Evaluate Essential Tremor. [2022]Background/Aims: Evaluation of tremor constitutes a crucial step from the diagnosis to the initial treatment and follow-up of patients with essential tremor. The severity of tremor can be evaluated using clinical rating scales, accelerometry, or electrophysiology. Clinical scores are subjectively given, may be affected by intra- and interevaluator variations due to different experience, delays between consultations, and subtle changes in tremor severity. Existing medical devices are not routinely used: they are expensive, time-consuming, not easily accessible. We aimed at showing that a smartphone application using the accelerometers embedded in smartphones is effective for quantifying the tremor of patients presenting with essential tremor. Methods: We developed a free iPhone/iPod application, Itremor, and evaluated different parameters on 8 patients receiving deep brain stimulation of the ventral intermediate nucleus of the thalamus: average and maximum accelerations, time above 1 g of acceleration, peak frequency, typical magnitude of tremor, for postural and action tremors, on and off stimulation. Results: We demonstrated good correlations between the parameters measured with Itremor and clinical score in all conditions. Itremor evaluation enabled higher discriminatory power and degree of reproducibility than clinical scores. Conclusion: Itremor can be used for routine objective evaluation of essential tremor, and may facilitate adjustment of the treatment. © 2015 S. Karger AG, Basel.
Rapid tremor frequency assessment with the iPhone accelerometer. [2017]The physician is often seeking more efficient ways of performing patient assessments. Currently, measuring tremor frequency requires expensive and bulky equipment. We propose the use of the in-built accelerometer of the iPhone via the iSeismo application for rapid measurement of tremor frequency. We use this device in a series of 7 different tremor cases, and show that the frequency measurements on the iSeismo graph closely match the more sophisticated EMG analysis during tremor. This is a preliminary confirmation of the usefulness of this device in the clinical setting for quick assessment of the dominant frequency component in a variety of tremors.