An observational study in Functional Neurological Disorder, sponsored by University of Colorado, Denver. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by University of Colorado, Denver · Observational
This study evaluates whether remotely measured daily activity behavior, captured through a thigh-worn accelerometer, can serve as a reliable and ecologically valid indicator of symptom impact in individuals with Functional Neurologic Disorder (FND). Current clinician-rated assessments capture only a single time point and do not reflect day-to-day symptom variability or functional impact. The study will (1) assess the feasibility of continuous activity monitoring in people with FND, (2) examine associations between activity behavior and established clinician- and patient-reported FND measures, and (3) qualitatively explore participants' lived experiences of daily activity. Findings aim to address a critical gap in understanding real-world function in this heterogeneous population.
Specific Aim 1:
Evaluate the feasibility of remotely assessed activity behavior with thigh-mounted accelerometry in 20 individuals with FND.
The feasibility of remotely assessed activity behavior in participants with FND will be determined based on: 1) enrollment of 20 participants with FND within 10 months, 2) ≥90% adherence to thigh-mounted accelerometer use based on wear time of ≥ 5 days, 3) retaining ≥90% participants with FND at Visit 2, and 4) ≥90% acceptability calculated as the proportion of participants with a response of 'somewhat agree' or better on a 7-point Likert scale asking about acceptability of the study procedures.
Specific Aim 2:
Determine differences in activity behaviors between people with functional neurologic disorder and healthy controls (CTL) over 7-10 days.
Physical activity will be measured by an accelerometer-based activity monitor (activPAL4, PAL Technologies). The thigh-mounted activPAL will be worn continuously for 7 days between visit 1 and visit 2. Primary variables of interest will include mean daily step count, total sedentary time, bouts of sedentary time > 30 min, and number of transitions to standing, and time standing and stepping in order to capture a full picture of free-living mobility and activity.
Specific Aim 3:
Explore the lived experiences of activity behavior in people with FND. Approach: Conduct individual, semi-structured interviews to explore the impact of FND symptoms on activity behavior and integrate these findings with quantitative activity measures to understand the influence on real-world activity.
Aim 3: The lived experience of activity behavior for people with FND will be assessed using a mixed-methods approach. Qualitative data will be analyzed using thematic analysis with deductive and inductive coding to develop qualitative interview themes. Quantitative activity behavior and qualitative interview data will be analyzed together to develop a more comprehensive understanding of the impact of FND on activity behavior.
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 37 observational studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Participants will be recruited at the University of Colorado Hospital outpatient physical therapy department and the Functional Neurologic Disorder Clinic at the University of Colorado.
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Participants with FND:
•Neurologist-confirmed diagnosis of functional neurologic disorder with motor symptoms, sensory symptoms, dizziness, and/or seizures
Healthy Controls:
Exclusion Criteria:
Participants with FND
Individuals aged 18-65 with neurologist confirmed functional neurological disorder
Individuals aged 18-65 who are roughly matched to people with FND for age and sex and free from major disease that affects mobility.
Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: enrollment
The feasibility of remotely assessed activity behavior in participants with FND will be determined based on: 1) enrollment of 20 participants with FND within 10 months
Time frame: 10 Months
Adherence to thigh-mounted accelerometer use
The feasibility of remotely assessed activity behavior in participants with FND will be determined based on: 2) ≥90% adherence to thigh-mounted accelerometer use based on wear time of ≥ 5 days
Time frame: From baseline through study completion, an average of 1 week.
Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: retainment
The feasibility of remotely assessed activity behavior in participants with FND will be determined based on: 3) retaining ≥90% participants with FND at Visit 2
Time frame: From baseline through study completion, an average of 1 week.
Acceptability of remotely assessed activity behavior with thigh-mounted accelerometry
The acceptability of remotely assessed activity behavior in participants with FND will be determined based on: ≥90% acceptability calculated as the proportion of participants with a response of 'somewhat agree' or better on a 7-point Likert scale asking about acceptability of the study procedures.
Time frame: Visit 2
Average daily steps
Physical activity (i.e., average daily steps) will be measured by an accelerometer-based activity monitor (activPAL4, PAL Technologies). The thigh-mounted activPAL will be worn continuously for 7 days between visit 1 and visit 2.
Time frame: Up to 7 days.
Discriminant and convergent validity of physical activity with clinician- and patient-rated FND outcomes.
Discriminant validity will be determined by comparing mean daily step count and sedentary time over the 7-day period between the FND and healthy groups. Convergent validity of activity behavior variables (i.e., daily step count, sedentary time, activity bouts) with clinician- and patient-rated FND outcomes will also be assessed. Clinician-Rated Outcomes: Participants with FND will complete the Simplified Functional Movement Disorder Rating Scale (S-FMDRS), 6 Minute Walk Test (6MWT), Timed Up and Go (TUG), and the Timed Up and Go Cognitive. Patient-Rated Outcomes: Participants will complete the Patient Health Questionnaire-15, Hospital Anxiety and Depression Scale, Modified Fatigue Impact Scale, PROMIS Ability to Participate in Social Activities, Exercise Self Efficacy Scale, Falls Efficacy Scale, and Godin Time Leisure Questionnaire.
Time frame: Patient and clinician rated measures will be performed at baseline and compared to activity behavior variables over the 7-day monitoring period.
Qualitative semi-structured interviews
The lived experience of activity behavior for people with FND will be assessed using a mixed-methods design approach. Qualitative data will be analyzed using thematic analysis with deductive and inductive coding to develop qualitative interview themes.
Time frame: At Visit 2 (approximately 7 days after Visit 1)
Plan to share: No — There is not an IPD plan for this study.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.
Of 16 observational studies under Conversion Disorder, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 55. This study's planned 12 months is below that.
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