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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Colorado, Denver

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: People with FND
Group B: Healthy Controls

Trial outcomes

Primary outcomes

1

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
2

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.
3

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.
4

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

Secondary outcomes

1

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.
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.

Time frame
Patient and clinician rated measures will be performed at baseline and compared to activity behavior variables over the 7-day monitoring period.
3

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)

Other outcomes

Sponsors and contacts

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