Treatment for Stroke

Phase-Based Estimates
1
Effectiveness
1
Safety
Cleveland Clinic Main Campus, Cleveland, OH
Stroke+6 More
Eligibility
18+
All Sexes
Eligible conditions
Stroke

Study Summary

This study is evaluating whether aerobic exercise can help improve function for individuals who have had a stroke.

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Eligible Conditions

  • Stroke
  • Brain Diseases
  • Vascular Diseases
  • Nervous System Diseases
  • Central Nervous System Diseases
  • Cerebrovascular Disorders
  • Cardiovascular Diseases

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 26 secondary outcomes in patients with Stroke. Measurement will happen over the course of end of treatment (8 weeks from Baseline).

Week 8
Left Ankle Range of Motion
Left Hip Range of Motion (coronal plane)
Left Hip Range of Motion (sagittal plane)
Left Hip Range of Motion (transverse plane)
Left Knee Range of Motion
Left Stance Time
Left Step Length
Left Step Width
Left Swing Time
Right Ankle Range of Motion
Right Hip Range of Motion (coronal plane)
Right Hip Range of Motion (sagittal plane)
Right Hip Range of Motion (transverse plane)
Right Knee Range of Motion
Right Stance Time
Right Step Length
Right Step Width
Right Swing Time
Walking Cadence
Walking Speed
Wolf Motor Function Test (WMFT)
Year 1
Action Research Arm Test (ARAT)
Center for Epidemiological Studies-Depression (CES-D)
Fugl-Meyer Assessment (FMA)
Modified Rankin Scale
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Six-Minute Walk Test (6MWT)
Stroke Impact Scale (SIS)

Trial Safety

Trial Design

2 Treatment Groups

Aerobic Exercise & Repetitive Task Practice

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Aerobic Exercise & Repetitive Task PracticeParticipants will perform the following: 45 minutes of cycling 45 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice Only
Behavioral
Participants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: end of treatment +1 year (14 months from baseline)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly end of treatment +1 year (14 months from baseline) for reporting.

Who is running the study

Principal Investigator
S. L.
Susan Linder, Project Scientist, Principle Investigator
The Cleveland Clinic

Closest Location

Cleveland Clinic Main Campus - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
with or without oxygen The person can walk at least 20 meters without help, and may need oxygen. show original
Within six months following a single stroke, either an ischemic or hemorrhagic type, confirmation by neuroimaging is required. show original
The person has a Fugl-Meyer motor score of 19-55 in the involved upper extremity. show original
People aged between 18 and 85 years old. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can stroke be cured?

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Stroke can be cured in a large percentage of patients. Even in the era of modern therapy, some patients can return to a normal life with minimal symptoms. A major challenge for treatment is to ensure good-quality, sustained medical care to patients with severe and chronic stroke.

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How many people get stroke a year in the United States?

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Approximately 230 thousand new cases of ischemic stroke were detected in 2003. Because these data are based on the same criteria as the Stroke and Transient Ischemic Attack (STROBE) observational study data, the total rate of stroke may have been higher. About 80,000 people per year in the United States may be affected by a nonfatal ischemic stroke, and 5,000 a year, by an ischemic stroke that is fatal within a year.

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What causes stroke?

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Risk factors for stroke include smoking (particularly passive smoking) and hypertension. These are in line with results from large-scale studies of the association of smoking and stroke. The major risk factor for stroke that is not smoking, and which therefore may have some effect on stroke risk in young adults and adolescents, is diabetes, which is a probable risk-increasing factor for the atherosclerotic diseases such as stroke by way of ischemic heart disease.

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What is stroke?

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As the number of people with neurological and neuropsychiatric symptoms increases the risk of stroke is also increasing. The first symptoms of stroke are typically stroke awareness and headaches; with this knowledge we need to be attentive in recognizing and taking appropriate action for stroke complaints.

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What are common treatments for stroke?

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Many aspects of stroke treatment are not standardized. The effectiveness of most of the treatments has a limited evidence base. Therefore, this article will focus on current or recommended treatments for acute cerebral infarction and its subtypes.

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What are the signs of stroke?

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Stroke can give rise to a number of stroke symptoms, including numbness, speech and/or vision disturbances, loss of eye movement, paralysis, and problems with speech, aphasia, or difficulty in concentrating. These symptoms may also arise from other causes of weakness of the limbs, such as muscular weakness due to diabetes, rheumatoid arthritis, or other condition(s) that affect mobility or causes muscular weakness. The patient's family doctor should be informed regarding possible non-stroke signs of stroke, so that the doctor's suspicion of stroke can be increased.

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What is the primary cause of stroke?

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Strokes that occur mostly in childhood are due to developmental abnormalities and congenital vascular malformations, which usually cause embolic infarction. Strokes that occur mostly in late adolescence and adulthood are due mainly to arterial atherosclerosis, which is characterized by nonobliterative stenosis caused by vascular fibrous hyperplasia, intimal thickening and thrombus formation (thromboangiitis obliterans). It is thought that the development of arterial atherosclerosis occurs in midlife or in middle age. It is generally thought that the development of thromboangiitis obliterans occurs most often in the third decade of life, but the timing of the first onset may vary widely in different patients.

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Has treatment proven to be more effective than a placebo?

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Although this meta-analysis did not show statistically significant evidence for superiority of treatment, the meta-analysis does suggest a reasonable possibility of no apparent benefit of treatment. Further large, well-designed trials are needed before definitive conclusions can be drawn.

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Is treatment safe for people?

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Most medical practitioners believe treatment poses no hazard to people. However, a significant minority has an opposing view on both safety and safety communication. Safety training programs aiming to reassure and educate patients as well as family members and health care professionals regarding potential risks of the treatment and possible risks for other patients are needed. The training should focus on the risk of stroke and other serious adverse events.

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Who should consider clinical trials for stroke?

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In general, people who are in the chronic state and/or who have no motivation to change, no money, no time, etc., would not participate in a clinical trial of any type. People can also consider clinical trials when they have some special reasons, not only medical but also financial, social, and so on. There was no evidence that physicians were more likely to agree to advise the patient to enroll in a clinical trial if he or she requested it but was unable to afford the treatment.

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What is the latest research for stroke?

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Stroke is the leading cause of disability and death worldwide. Prevention of strokes is an important clinical priority. There are four phases of the disease with different severity. The pathogenesis of stroke is still incompletely understood due to limited research capability and a lack of consensus on standardized definitions, diagnosis and epidemiologic studies. This article discusses the latest research developments in stroke prevention.

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Does stroke run in families?

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This report provides an overview of the familial history of cerebrovascular disease in a large group of patients. While stroke does run in some families, it cannot be considered a major genetic risk factor, when measured in isolation. A large number of stroke cases could not be ascertained to permit a search of these families for the gene encoding cerebral amyloid angiopathy (CAA) and/or apolipoprotein E. Our family case study does not indicate a major role for CAA or APOE gene as a major risk factor for stroke.

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