- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07372755
Feasibility and Usability of a Mobile App for Monitoring and Managing Functional Movement Disorders
People with FMD may experience symptoms such as tremor, jerks, spasms, or difficulty walking. These symptoms are not caused by damage to the brain or nerves. Instead, they happen because the brain is not sending or processing signals in the usual way. Symptoms can change from day to day, and stress, emotions, or certain situations may make them better or worse.
Right now, patients are often asked to remember how their symptoms have been since their last clinic visit or to write things down in a notebook. This can be hard to do and may not give an accurate picture of what is happening. Because of this, doctors and patients may miss important patterns or triggers, and it can be harder to know which coping strategies are helpful.
To improve this, our team has created a mobile app that allows people with FMD to easily record their symptoms, stress level, and mood, in real time. The app also includes simple self-help tools that may support symptom management. Before using this app more widely, we want to find out (1) whether patients can use it as intended and (2) whether they find it easy and helpful to use. This study will help us understand if the app is practical for use in an FMD clinic and how it could be improved.
Study Overview
Status
Conditions
Detailed Description
Functional movement disorders (FMD) can cause symptoms such as tremor, jerking, or walking difficulties. These symptoms are not due to structural damage in the brain or nerves but relate to how the brain is functioning. Symptoms often vary over time and may be affected by stress, emotions, and everyday situations, which can be hard to track accurately between clinic visits.
This study will evaluate the feasibility and usability of a mobile application designed to help people with FMD record symptom flares, stress levels, and possible triggers, and access simple self-help tools. The app also produces summary reports that can be reviewed during clinic visits.
Ten adults with FMD will use the app for six weeks. Participants on the first visit will be given brief training about the app. Follow-up visits will be every two weeks to review app summaries and address technical issues. At week 6, participants will complete a short usability questionnaire and a brief interview about their experience.
The study's main goal is to determine whether participants can and will use the app as intended and whether they find it acceptable and easy to use
We invite you to take part in a research study looking at a new mobile phone app designed for people with Functional Movement Disorders (FMD). Taking part is completely voluntary.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Aditya Murgai, MBBS MD DM
- Phone Number: 15196633121
- Email: aditya.murgai@lhsc.on.ca
Study Locations
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London, Canada, N6A5A5
- University Hospital
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Contact:
- Aditya Murgai, MBBS
- Phone Number: 5196633121
- Email: murgai03@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18
- Diagnosed with a functional movement disorder
- Own a smartphone
- Ability to read and understand English
- Ability to provide informed consent
Exclusion Criteria:
- Acute psychiatric crisis
- Limitations that make it impossible to use a smartphone app
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Functional Movement Disorder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility: Can patients use the app as intended for 6 weeks?
Time Frame: 6 weeks
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Can patients use the app as intended for 6 weeks?
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6 weeks
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Acceptability and Usability
Time Frame: 6 weeks
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Do patients find the app acceptable and easy to use?
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Utility
Time Frame: 6 weeks
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Do app summaries feel clinically useful during visits?
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6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 128351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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