About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Roughly matched to participants with FND for age and sex
Free from major disease that affects mobility (e.g., neurologic, movement, cardiac, pulmonary, renal, and psychiatric disorders) by history.
Disqualifiers
Physical or cognitive symptoms impairing ability to engage with the protocol (e.g., seizure frequency > 10/day).
Diagnosis of other major neurologic, cardiovascular, musculoskeletal, or psychiatric disorder that affects mobility as determined by the principal investigator
Trial population
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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
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
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.
Secondary outcomes
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.
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.
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.
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