Functional Neurological DisorderNCT07478666
Feasibility of Remotely Measured Activity Behavior for Individuals With Functional Neurologic Disorder
An observational study of Functional Neurological Disorder, run by University of Colorado, Denver at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Neurological Disorder
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 16 Apr 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Denver, CO, 80238
Elliot J Gann, PT, DPT, 6502820897, elliot.gann@cuanschutz.edu
About this study
Official title: Feasibility and Construct Validity 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.
Read the detailed description
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.
- Conditions
- Functional Neurological Disorder
- Keywords
- functional neurological disorder
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Visit 2
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At Visit 2 (approximately 7 days after Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start16 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478666
- Sponsor's protocol ID
- COMIRB 25-2380
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not an IPD plan for this study.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Construct Validity of Remotely Measured Activity Behavior for Individuals With Functional Neurologic Disorder
- ClinicalTrials.gov ID
- NCT07478666
- Acronym / sponsor ID
- COMIRB 25-2380
- Conditions
- Functional Neurological Disorder
- Keywords
- functional neurological disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- •Neurologist-confirmed diagnosis of functional neurologic disorder with motor symptoms, sensory symptoms, dizziness, and/or seizures
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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.
3 secondary outcomes
Average daily steps
Time frame: Up to 7 days.
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.
Qualitative semi-structured interviews
Time frame: At Visit 2 (approximately 7 days after Visit 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. There is not an IPD plan for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Neurological Disorder, run by University of Colorado, Denver at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elliot J Gann, DPT (650-282-0897, elliot.gann@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: enrollment (time frame: 10 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.