Proactive Perturbations for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SC
Stroke
Proactive Perturbations - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Post-stroke Perturbation Training

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Proactive Perturbations will improve 1 primary outcome and 18 secondary outcomes in patients with Stroke. Measurement will happen over the course of 8 weeks (pre-intervention; post-intervention).

Week 32
Fall incidence
8 weeks (pre-intervention; post-intervention)
Activities-specific Balance Confidence scale
Angular momentum modulation (leg perturbations) Largest rejected perturbation (trunk)
Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)
Angular momentum modulation (trunk perturbations) Largest rejected perturbation (trunk)
Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)
Center of pressure shift stabilization strategy (mechanics)
Center of pressure shift stabilization strategy (peroneus longus activity)
Fear of falling
Foot placement stabilization strategy (gluteus medius activity)
Foot placement stabilization strategy (mechanics)
Functional Gait Assessment
Largest rejected perturbation (leg) Largest rejected perturbation (trunk)
Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)
Largest rejected perturbation (trunk) Largest rejected perturbation (trunk)
Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)
Push-off stabilization strategy (mechanics)
Push-off stabilization strategy (medial gastrocnemius activity)
Walking speed

Trial Safety

Trial Design

2 Treatment Groups

Reactive Perturbations
1 of 2
Proactive Perturbations
1 of 2
Experimental Treatment

This trial requires 86 total participants across 2 different treatment groups

This trial involves 2 different treatments. Proactive Perturbations is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Reactive Perturbations
Behavioral
Proactive Perturbations
Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 32 weeks (12-week period pre-intervention; 12-week period post-intervention)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 32 weeks (12-week period pre-intervention; 12-week period post-intervention) for reporting.

Who is running the study

Principal Investigator
J. D.
Prof. Jesse Dean, PhD
Medical University of South Carolina

Closest Location

Medical University of South Carolina - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Experience of a stroke at least 6 months prior to participation
Self-reported experience of a fall in the previous year, and/or a fear of falling
Gait speed of at least 0.2 m/s
Ability to walk on a treadmill without a cane or walker
Provision of informed consent

Patient Q&A Section

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

"The number of people with stroke is about 9.2 million a year. This is 13% of all stroke cases, 15% of all strokes, and 6% of all stroke-related deaths. Stroke is the most common cause of death in the United States. Stroke is also more common in the South than in the Northeast or the Midwest. Stroke is more common in the South than in the Midwest and in both the South and the Midwest than in the Northeast. These statistics suggest that stroke is not an under-recognized and under-treated epidemic disorder in the United States. The data underscore the need for a large scale, rigorous effort to more rapidly establish stroke diagnosis and treatment programs throughout the country." - Anonymous Online Contributor

Unverified Answer

Can stroke be cured?

"We found a higher mortality and unfavorable outcome in patients with moderate or severe strokes who received the conservative treatment as compared to patients without strokes who received the conservative treatment. Recent findings suggests the need for more precise diagnostic markers and further studies to identify those risk profiles that will aid stratification." - Anonymous Online Contributor

Unverified Answer

What is stroke?

"Stroke is a disorder that arises from a brain blood vessel occlusion and occurs within the brain. It typically involves weakness on the affected side of the body and is sometimes associated with sensory disturbances. Stroke is the biggest single cause of death due to disease in Europe. It is the most important cause of disability, affecting over half of those affected.\n" - Anonymous Online Contributor

Unverified Answer

What causes stroke?

"Stroke is a multitude of separate causes, though often simplified as the result of a blood clot occluding a blood vessel in the brain. Risk factors often include smoking, cholesterol, hypertension, diabetes, high blood pressure and family history. Strokes can occur through a variety of mechanisms, including hematoma rupture, embolization, and other causes. The brain injury can be a result of blood clot rupture, embolization or disruption of blood flow." - Anonymous Online Contributor

Unverified Answer

What are common treatments for stroke?

"Results from a recent clinical trial support the use of medication to control acute stroke symptoms, including antiplatelet agents (such as aspirin), dipyridamole, and nonsteroidal anti-inflammatory drugs (NSAIDS). In addition to these medications, a number of other medications were found to be helpful (e.g., blood pressure medications, statins, and anticoagulants). There is some evidence supporting the use of beta-blockers, and steroids for the treatment of mild-to-moderate strokes. Anticoagulants, antidiabetic medications (including oral hypoglycemic agents), and antihistamines and/or decongestants may also be helpful." - Anonymous Online Contributor

Unverified Answer

What are the signs of stroke?

"Signs and symptoms of stroke are usually sudden in onset, serious, and present over a short time period. The main signs of stroke are weakness on one side of the body, confusion, slurred speech, or decreased level of consciousness. Patients should be assessed for signs for bleeding in the brain by CT scans, CTP, or MR. An elevated creatinine level and decreased level of urine can also suggest stroke." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of stroke?

"High blood pressure and diabetes are the major causes of ischaemic stroke, accounting for approximately one-third of cases each, with stroke being predominantly caused by cardioembolic and lacunar strokes. High blood pressure is the major cause of small vessel disease, accounting for over one-third of cases, and lacunar stroke for about 15%. A quarter of strokes were due to undetermined and other causes." - Anonymous Online Contributor

Unverified Answer

How serious can stroke be?

"There seems to be little correlation between age and severity of the stroke. There would be a need to understand if there is a sex difference and why women had strokes that were worse than men did. Data from a recent study are a strong reminder that stroke is the leading cause of disability as measured in health care expenses in all age groups. Strokes are devastating to both males and females." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets stroke?

"Given that stroke can occur at any age, we used the average age of stroke in US population from NHANES (2001-2010) (i.e., 63.8, 67.8, 69.4, 66.4, 73.4 yr). The projected stroke prevalence in US population by 2080 is 1.0." - Anonymous Online Contributor

Unverified Answer

What is proactive perturbations?

"In summary, this study provides empirical insight into the relationship between perturbations and reactive adaptation and suggests that proactive perturbations, which mimic the actual perturbation and may happen after the perturbation, elicit less short-term (reactive adaptation) than do reactive perturbations that occur during the perturbation. This suggests that reactive adaptation can be explained by a short-term model and proactive perturbations by a longer term model." - Anonymous Online Contributor

Unverified Answer

Has proactive perturbations proven to be more effective than a placebo?

"Results from a recent paper of the study support the validity of the assumption that a single-session of perturbation combined with conventional training would be more effective than a placebo for prevention of stroke and for enhancing cerebral blood flow during acute phase." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for stroke?

"All patients and all health professionals must be offered full and timely informed informed consent of PVS from pre-operatively, post-intubation or through the patient's legal guardian before commencing stroke research, including clinical trials for stroke. Patients must understand that their treatment might, as well as the treatment itself, have side effects. Health professionals must be adequately informed about the risk of death and disability of PVS patients, which is increased in clinical research. Further, there must be a clear definition of 'benefits' and 'harm' of research, the research objectives must be justified, and there must be adequate safeguards against abuse of data and patients by those conducting research." - Anonymous Online Contributor

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