Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07478666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Remotely Measured Activity Behavior for Individuals With Functional Neurologic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003291', 'term': 'Conversion Disorder'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: enrollment', 'timeFrame': '10 Months', 'description': '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'}, {'measure': 'Adherence to thigh-mounted accelerometer use', 'timeFrame': 'From baseline through study completion, an average of 1 week.', 'description': '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'}, {'measure': 'Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: retainment', 'timeFrame': 'From baseline through study completion, an average of 1 week.', 'description': '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'}, {'measure': 'Acceptability of remotely assessed activity behavior with thigh-mounted accelerometry', 'timeFrame': 'Visit 2', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Average daily steps', 'timeFrame': 'Up to 7 days.', 'description': '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.'}, {'measure': 'Discriminant and convergent validity of physical activity with clinician- and patient-rated FND outcomes.', 'timeFrame': 'Patient and clinician rated measures will be performed at baseline and compared to activity behavior variables over the 7-day monitoring period.', 'description': '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.\n\nClinician-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.\n\nPatient-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.'}, {'measure': 'Qualitative semi-structured interviews', 'timeFrame': 'At Visit 2 (approximately 7 days after Visit 1)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['functional neurological disorder'], 'conditions': ['Functional Neurological Disorder']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Specific Aim 1:\n\nEvaluate the feasibility of remotely assessed activity behavior with thigh-mounted accelerometry in 20 individuals with FND.\n\nThe 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.\n\nSpecific Aim 2:\n\nDetermine differences in activity behaviors between people with functional neurologic disorder and healthy controls (CTL) over 7-10 days.\n\nPhysical 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.\n\nSpecific Aim 3:\n\nExplore 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.\n\nAim 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants with FND:\n\n•Neurologist-confirmed diagnosis of functional neurologic disorder with motor symptoms, sensory symptoms, dizziness, and/or seizures\n\nHealthy Controls:\n\n* Roughly matched to participants with FND for age and sex\n* Free from major disease that affects mobility (e.g., neurologic, movement, cardiac, pulmonary, renal, and psychiatric disorders) by history.\n\nExclusion Criteria:\n\nParticipants with FND\n\n* Physical or cognitive symptoms impairing ability to engage with the protocol (e.g., seizure frequency \\> 10/day).\n* Diagnosis of other major neurologic, cardiovascular, musculoskeletal, or psychiatric disorder that affects mobility as determined by the principal investigator'}, 'identificationModule': {'nctId': 'NCT07478666', 'briefTitle': 'Feasibility of Remotely Measured Activity Behavior for Individuals With Functional Neurologic Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Feasibility and Construct Validity of Remotely Measured Activity Behavior for Individuals With Functional Neurologic Disorder', 'orgStudyIdInfo': {'id': 'COMIRB 25-2380'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'People with FND', 'description': 'Individuals aged 18-65 with neurologist confirmed functional neurological disorder'}, {'label': 'Healthy Controls', 'description': 'Individuals aged 18-65 who are roughly matched to people with FND for age and sex and free from major disease that affects mobility.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Elliot J Gann, DPT', 'role': 'CONTACT', 'email': 'elliot.gann@cuanschutz.edu', 'phone': '650-282-0897'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not an IPD plan for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Instructor', 'investigatorFullName': 'Elliot Gann', 'investigatorAffiliation': 'University of Colorado, Denver'}}}}