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Intensive Walking Therapy for Stroke Rehabilitation (VIEWS-2 Trial)

N/A

Recruiting

Led By George Hornby

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to sit > 30 seconds without upper-extremity support or physical assistance

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 8-10 weeks

Awards & highlights

VIEWS-2 Trial Summary

This trial will study how rehab exercises and intensity affect stroke patients' walking, how they move in their community, and their quality of life.

Who is the study for?

This trial is for individuals who had a stroke 1-6 months ago, can walk at least 10 meters with or without help but not faster than 1.0 m/s, and can follow simple commands. They must be able to sit unaided for over half a minute and have medical clearance to participate. People with severe heart issues, walking limitations before the stroke, or certain other health conditions cannot join.Check my eligibility

What is being tested?

The study tests how well different physical therapy strategies work after a stroke. It compares high-intensity vs low-intensity exercises and task-specific (like walking) vs non-specific activities on patients' ability to move around and their quality of life.See study design

What are the potential side effects?

Since this trial involves physical therapy interventions rather than medications, side effects may include muscle soreness, fatigue, joint pain or discomfort related to increased physical activity levels during the rehabilitation process.

VIEWS-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can sit for more than 30 seconds without help or using my arms for support.

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I can make my own medical decisions or have someone legally appointed to do so.

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I have weakness on one side of my body but no balance issues.

VIEWS-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 8-10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 8-10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 8-10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in 6 minute walk test

Changes in gait speed

Secondary outcome measures

Changes in community mobility

Changes in gait biomechanics

Changes in measures of physical participation

+2 more

VIEWS-2 Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: High-intensity, task-specific (i.e., walking) interventionsExperimental Treatment1 Intervention

30 1-hour (hr) sessions of walking training targeting higher cardiovascular intensities over approximately 2 months

Group II: Low-intensity, non-specific physical therapy interventionsActive Control1 Intervention

30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months

Group III: High-intensity, non-specific physical therapy interventionsActive Control1 Intervention

30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting higher cardiovascular intensities over approximately 2 months

Group IV: Low-intensity, task-specific physical therapy interventionsActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,630 Total Patients Enrolled

79 Trials studying Stroke

5,287 Patients Enrolled for Stroke

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,176 Total Patients Enrolled

13 Trials studying Stroke

3,962 Patients Enrolled for Stroke

Northwestern UniversityOTHER

1,586 Previous Clinical Trials

917,151 Total Patients Enrolled

30 Trials studying Stroke

25,105 Patients Enrolled for Stroke

Media Library

High-intensity, non-specific physical therapy interventions Clinical Trial Eligibility Overview. Trial Name: NCT05727930 — N/A

Stroke Research Study Groups: Low-intensity, non-specific physical therapy interventions, High-intensity, non-specific physical therapy interventions, Low-intensity, task-specific physical therapy interventions, High-intensity, task-specific (i.e., walking) interventions

Stroke Clinical Trial 2023: High-intensity, non-specific physical therapy interventions Highlights & Side Effects. Trial Name: NCT05727930 — N/A

High-intensity, non-specific physical therapy interventions 2023 Treatment Timeline for Medical Study. Trial Name: NCT05727930 — N/A

Frequently Asked Questions

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

Is there an upper age limit for eligibility in this clinical trial?

"Those eligible to participate in this medical study must be between 18 and 85 years old."

Answered by AI

What is the current size of the participant pool in this clinical trial?

"Affirmative. Per the information provided on clinicaltrials.gov, this medical study is actively seeking participants as of February 6th 2023 after being initially posted on November 1st 2023. The trial requires 100 volunteers to be enrolled at a single site."

Answered by AI

Are there any vacancies for participants in this experiment?

"According to information readily available on clinicaltrials.gov, this trial is actively seeking participants. The study was first published and made publically viewable on 11 January 2023 with the latest updates added 6 February 2021."

Answered by AI

What objectives does this research endeavor seek to accomplish?

"During the 8-10 week duration of this trial, investigators will be primarily measuring changes in 6 minute walk test. Secondary outcomes being assessed include alterations to community mobility (steps taken daily), gait biomechanics, and VO2peak during peak treadmill speed."

Answered by AI

Do I qualify to be a participant in this clinical trial?

"This study's criteria necessitates the inclusion of 100 patients aged 18-85 who have experienced a stroke in the subacute period (1-6 months). Additionally, participants must demonstrate hemiparesis on Fugl Meyer < 34 and display an ability to ambulate with or without physical support over 10 metres but not exceeding 1.0 m/s; assistive devices and below knee bracing are permitted. Moreover, individuals should be able to sit for more than 30 seconds unaided as well as comprehend three step commands. Each participant must provide informed consent and receive medical clearance from their practitioner before enrolling in this clinical trial."

Answered by AI

Recent research and studies

Neurorehabilitation and Neural RepairJournal

Feasibility and Potential Efficacy of High-intensity Stepping Training in Variable Contexts in Subacute and Chronic Stroke

Holleran, Carey L., Don D. Straube, Catherine R. Kinnaird, Abigail L. Leddy, and T. George Hornby. 2014. “Feasibility and Potential Efficacy of High-intensity Stepping Training in Variable Contexts in Subacute and Chronic Stroke”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968314521001.

Neurorehabilitation and Neural RepairJournal

Variable Intensive Early Walking Poststroke (VIEWS)

Hornby, T. George, Carey L. Holleran, Patrick W. Hennessy, Abigail L. Leddy, Mark Connolly, Jaclyn Camardo, Jane Woodward, Gordhan Mahtani, Linda Lovell, and Elliot J. Roth. 2015. “Variable Intensive Early Walking Poststroke (VIEWS)”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968315604396.

StrokeJournal

Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke

Hornby, T. George, Christopher E. Henderson, Abbey Plawecki, Emily Lucas, Jennifer Lotter, Molly Holthus, Gabrielle Brazg, et al.. 2019. “Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.119.026254.

Neurorehabilitation and Neural RepairJournal