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

NCT07478666 | Recruiting

• 1 other identifier: COMIRB 25-2380
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Neurological Disorder

Keywords

functional neurological disorder

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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.

  Visit 2

Secondary Outcomes (3)

• Average daily steps

  Up to 7 days.

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

  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

  At Visit 2 (approximately 7 days after Visit 1)

Study Arms (2)

People with FND

Individuals aged 18-65 with neurologist confirmed functional neurological disorder

Healthy Controls

Individuals aged 18-65 who are roughly matched to people with FND for age and sex and free from major disease that affects mobility.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Denver, CO, 80238, Canada

RECRUITING

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Central Study Contacts

Elliot J Gann, DPT

CONTACT

650-282-0897; elliot.gann@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 17, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)