RECRUITING

Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function, community mobility and quality of life in patients with subacute (1-6 months) post-stroke.

Official Title

Variable Intensive Early Walking Post-Stroke -2 (VIEWS-2)

Quick Facts

Study Start:2023-01-11

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05727930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Sub-acute stroke (1-6 months) * Hemiparesis (Fugl-Meyer \<34) without cerebellar deficits * Ability to ambulate with or without physical assistance over 10 meters but \< 1.0 m/s and assistive devices and below-knee bracing is allowed. * Ability to sit \> 30 seconds without upper-extremity support or physical assistance * Ability to follow 3-step commands * Provision of informed consent and medical clearance from a supervising physician or medical provider to participate * Must have the ability to consent or have a legal health care power of attorney or legally authorized representative to consent for participation on their behalf	* Significant cardiovascular, metabolic, or respiratory disease that limits exercise participation (e.g. previous myocardial infarction \< 3 months prior, uncompensated congestive heart failure, resting blood pressure \> 210/110 mmHg, uncontrolled diabetes, end-stage renal disease, severe infectious or psychiatry disease, or advanced malignancy) * If during the graded-treadmill exercise evaluation, the participant presents with absolute criteria for termination of exercise testing during initial testing (e.g. moderate to severe angina, ST elevation \> 1.0mm without preexisting Q wave secondary to prior MI, signs of poor perfusion, etc). * Any orthopedic or neurological disorders that limited walking to \<50m prior to stroke onset. * Cannot receive physical therapy once baseline testing begins * If patients are prescribed botulinum toxin for their lower extremities will be excluded only if the dosage for any specific muscle is \>50 units in leg muscles above the knee. If doses are \> than 50 units in leg muscles below the knee, the participant will use an ankle-foot orthosis to minimze contributions of those mscles to locomotor function.

Inclusion Criteria

Exclusion Criteria

* Sub-acute stroke (1-6 months)
* Hemiparesis (Fugl-Meyer \<34) without cerebellar deficits
* Ability to ambulate with or without physical assistance over 10 meters but \< 1.0 m/s and assistive devices and below-knee bracing is allowed.
* Ability to sit \> 30 seconds without upper-extremity support or physical assistance
* Ability to follow 3-step commands
* Provision of informed consent and medical clearance from a supervising physician or medical provider to participate
* Must have the ability to consent or have a legal health care power of attorney or legally authorized representative to consent for participation on their behalf

* Significant cardiovascular, metabolic, or respiratory disease that limits exercise participation (e.g. previous myocardial infarction \< 3 months prior, uncompensated congestive heart failure, resting blood pressure \> 210/110 mmHg, uncontrolled diabetes, end-stage renal disease, severe infectious or psychiatry disease, or advanced malignancy)
* If during the graded-treadmill exercise evaluation, the participant presents with absolute criteria for termination of exercise testing during initial testing (e.g. moderate to severe angina, ST elevation \> 1.0mm without preexisting Q wave secondary to prior MI, signs of poor perfusion, etc).
* Any orthopedic or neurological disorders that limited walking to \<50m prior to stroke onset.
* Cannot receive physical therapy once baseline testing begins
* If patients are prescribed botulinum toxin for their lower extremities will be excluded only if the dosage for any specific muscle is \>50 units in leg muscles above the knee. If doses are \> than 50 units in leg muscles below the knee, the participant will use an ankle-foot orthosis to minimze contributions of those mscles to locomotor function.

Contacts and Locations

Study Contact

George Hornby

CONTACT

317-329-2353

tghornby@iu.edu

Chris Henderson

CONTACT

317-329-2353

henderce@iu.edu

Principal Investigator

George Hornby

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254

United States

Collaborators and Investigators

Sponsor: Indiana University

George Hornby, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-11

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-01-11

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

acute
walking deficits

Additional Relevant MeSH Terms

Stroke