Steps for Epilepsy (NCT05359003) | Clinical Trial Compass
CompletedNot Applicable
Steps for Epilepsy
United States26 participantsStarted 2023-02-13
Plain-language summary
The purpose of this research study is to evaluate the feasibility of a 12-week, telehealth delivered, step-goal based physical activity intervention in people with epilepsy. The study team will also evaluate the physical activity profiles of people with epilepsy both at rest and when engaged in physical activity and gather information on the effect of the intervention on epilepsy and epilepsy associated comorbidities.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* Focal or generalized epilepsy, as determined clinically by a WFBH epileptologist with no significant consideration of an alternative diagnosis
* Access to a smartphone with application capabilities
* Internet access or cellular data plan to attend virtual sessions
* Able to ambulate independently
Exclusion Criteria:
* Diagnosis of nonepileptic or psychogenic spells
* Seizures associated with falls with injury (such as atonic seizures)
* Medical conditions that would limit ability to participate in an exercise intervention including: Stage III or IV Congestive Heart Failure (CHF); End-stage Renal Disease; Severe dementia or significant cognitive impairment that precludes participation in the intervention or limits ability to follow the study protocol; Uncontrolled hypertension (HTN) defined as systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 110 mmHg at rest; Severe arthritis, amputations, or orthopedic problems that limit ambulatory ability
* Currently pregnant or plan to become pregnant during the study period (16 weeks)
* An active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
* Any clinically significant psychiatric illness, psychological, or behavioral problems that would interfere with the subject's ability to p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence
Timeframe: Week 12 to Week 16
2
Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability