Who is eligible for clinical trial NCT07039305?

Participants must meet protocol criteria for Stroke. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07039305 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-12-01

Physical Capacity Building for Chronic Stroke (NCT07039305)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Medical University of South Carolina

🩺 Plain-English Summary (8th-Grade Level)

Cardiac rehabilitation is the standard-of-care treatment option for patients with cardiovascular disease and has been shown to improve many aspects critical to patient recovery. Investigators believe that individuals who have had a stroke need to be treated similarly. Investigators will study the effects of a comprehensive modified cardiac rehabilitation program to determine if it can improve some of the physical and psychosocial problems common in survivors of stroke with and without depression.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (15 items).

Location: Medical University of South Carolina — Charleston, South Carolina

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age 18-80
A diagnosis of stroke at least 6 months prior
Residual paresis in the lower extremity (Fugl-Meyer lower extremity \[LE\] motor score \<34)
Ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-1.0 m/s
Ability to follow instructions, complete cognitive testing and to communicate exertion, pain and distress
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)
HDRS17 question #3 and PHQ-9 question #9 regarding suicide ≤ 2
Provision of informed consent. In addition, depressed subjects will screen for probable major depressive disorder (Patient Health Questionnaire-9 ≥ 10) and be diagnosed using the Structured Clinical Interview for Depression (SCID) according to the DSM-5.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Unable to ambulate at least 150 feet or experienced intermittent claudication while walking
Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
Dementia
Life expectancy \<1 yr
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 suicidal risk assessed by depression screening
Current enrollment in a rehabilitation trial to enhance motor, cognitive and or psychosocial recovery
Severe cognitive impairment (MoCA score ≤15)
Moderate to severe neglect that precludes cognitive testing For brain stimulation procedures only:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Medical University of South Carolina — Charleston, South Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗