Exercise program for stroke recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial involves individuals who have experienced a stroke at least six months prior and continue to face challenges with walking. Participants will be randomly assigned to either moderate or vigorous intensity walking exercise, conducted with a physical therapist for 45 minutes, three times a week over a 12-week period. The effectiveness of these exercise protocols will be evaluated through assessments of walking function at various intervals, with evaluators unaware of the participants' assigned groups. The goal is to determine which intensity of exercise leads to better walking outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 30-85 years at time of consenting
* Hemiparesis from ischemic and/or hemorrhagic strokes
* Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
* Walking speed \<1.0 m/s on the 10-meter walk test
* Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
* Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
* Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \<6 metabolic equivalents)
* Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

Exclusion Criteria:

* Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
* Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
* Hospitalization for cardiac or pulmonary disease within past 3 months
* Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
* Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
* Severe lower limb spasticity (Ashworth \>2)
* Known recent history (\<3 months) of unstable substance abuse or unstable mental illness
* Major post-stroke depression (Patient Health Questionnaire \[PHQ-9\] ≥ 10) in the absence of depression management by a health care provider
* Currently participating in physical therapy or another interventional study targeting walking function
* Recent (\<2 weeks) or planned changes in lower limb orthotic or spasticity management
* Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
* Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
* Unable to walk outside the home prior to stroke
* Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
* Pregnancy
* Previous exposure to fast treadmill walking (\>3 cumulative hours) in the past year

Where it's running

• University of Delaware
  Newark, Delaware, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• University of Cincinnati
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Pierce Boyne, PT, DPT, PhD — University of Cincinnati
• Study coordinator: Audrey Nicoloff
• Email: strokerecovery@uc.edu
• Phone: 513-558-7487

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Stem cell therapy for chronic stroke recovery

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  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

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  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

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  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.