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New treatment option for Stroke
Official title Physical Capacity Building for Chronic Stroke
ClinicalTrials.gov ID: NCT07039305
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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 people will screen for probable major depressive disorder (Patient Health Questionnaire-9 ≥ 10) and be diagnosed using the Structured Clinical Interview for...
- 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:
- Electronic or metallic implants
- History of seizures
- Women of child bearing potential
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.