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NCT Number: NCT07478666

Feasibility of Remotely Measured Activity Behavior for Individuals With Functional Neurologic Disorder

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Denver, CO, 80238, Canada

Location status: Recruiting

Location contact

Elliot J Gann, PT, DPT

CONTACT

[email protected]

6502820897

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants with FND:

•Neurologist-confirmed diagnosis of functional neurologic disorder with motor symptoms, sensory symptoms, dizziness, and/or seizures

Healthy Controls:

  • 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.

Exclusion criteria

Participants with FND

  • 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

Treatment and study plan

Primary outcomes

  1. Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: enrollment

    Time frame: 10 Months

    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. Adherence to thigh-mounted accelerometer use

    Time frame: From baseline through study completion, an average of 1 week.

    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

  3. Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: retainment

    Time frame: From baseline through study completion, an average of 1 week.

    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

  4. Acceptability of remotely assessed activity behavior with thigh-mounted accelerometry

    Time frame: Visit 2

    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

  1. Average daily steps

    Time frame: Up to 7 days.

    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.

  2. Discriminant and convergent validity of physical activity with clinician- and patient-rated FND outcomes.

    Time frame: Patient and clinician rated measures will be performed at baseline and compared to activity behavior variables over the 7-day monitoring period.

    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.

  3. Qualitative semi-structured interviews

    Time frame: At Visit 2 (approximately 7 days after Visit 1)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elliot J Gann, DPT

CONTACT

[email protected]

650-282-0897

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Feasibility and Construct Validity of Remotely Measured Activity Behavior for Individuals With Functional Neurologic Disorder

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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