Status:
COMPLETED
Post-Stroke Optimization of Walking Using Explosive Resistance
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Stroke
Depression
Eligibility:
All Genders
50-70 years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Depression is the most common neuropsychiatric manifestation following stroke and current treatments are largely ineffective. Depression has both direct and indirect effects on response to rehabilitat...
Eligibility Criteria
Inclusion
- 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
- 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 anti-seizure medications
- Current enrollment in a clinical trial to enhance motor recovery
- Pregnancy
Key Trial Info
Start Date :
February 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03826771
Start Date
February 6 2019
End Date
May 12 2024
Last Update
April 24 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425