Post-Stroke Optimization of Walking Using Explosive Resistance (NCT03826771) | Clinical Trial Compass
CompletedPhase 2
Post-Stroke Optimization of Walking Using Explosive Resistance
United States48 participantsStarted 2019-02-06
Plain-language summary
The investigators will study the effects of a 12 week strength training program on individuals who have had a stroke and are depressed to see if this type of exercise training helps treat depression and improves walking function. Our goal is to use the information collected in this study to help design treatments for people who have had a stroke that will help with many of the common consequences of stroke, including depression, muscle weakness and slow walking. Progress toward overcoming some of these issues would be incredibly valuable to any person who has had a stroke and their families.
Who can participate
Age range
50 Years – 70 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 50-70
* stroke within the past 6 to 60 months
* residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
* ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s
* no antidepressant medications or no change in doses of psychotropic medication for at least 4 weeks prior to the study (6 weeks if newly initiated medication)
* HRSD question #9 regarding suicide \<2; and 7) provision of informed consent.
Exclusion Criteria:
* Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
* history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
* History of COPD or oxygen dependence
* Preexisting neurological disorders, dementia or previous stroke
* History of major head trauma
* Legal blindness or severe visual impairment
* history of psychosis or other Axis I disorder that is primary
* Life expectancy \<1 yr.
* Severe arthritis or other problems that limit passive ROM
* History of DVT or pulmonary embolism within 6 months
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
* Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
* attempt of suicide in the last 2 years or at suicidal risk assessed by SCID interview
* History of seizures or currently prescribed …
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
Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression
Timeframe: Visit 1 through visit 24 (up to 12 weeks)