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

NCT05727930 | Recruiting DMC

• 2 other identifiers: IU-167671R01HD108622
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

acute; walking deficits

Outcome Measures

Primary Outcomes (1)

• Changes in 6 minute walk test

  Changes in 6 min walk test from baseline to post-training

  Approximately 8-10 weeks

Secondary Outcomes (6)

• Changes in community mobility

  Approximately 8-10 weeks

• Changes in measures of physical participation

  Approximately 8-10 weeks

• Changes in gait biomechanics

  Approximately 8-10 weeks

• Changes in peak metabolic capacity (VO2peak) during peak treadmill speed

  Approximately 8-10 weeks

• Changes in peak treadmill speed during the graded-exercise test

  Approximately 8-10 weeks

Study Arms (4)

High-intensity, task-specific (i.e., walking) interventions

EXPERIMENTAL

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

Behavioral: High-intensity, task-specific (i.e., walking) interventions

High-intensity, non-specific physical therapy interventions

ACTIVE COMPARATOR

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

Behavioral: High-intensity, non-specific physical therapy interventions

Low-intensity, task-specific physical therapy interventions

ACTIVE COMPARATOR

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

Behavioral: Low-intensity, task-specific physical therapy interventions

Low-intensity, non-specific physical therapy interventions

ACTIVE COMPARATOR

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

Behavioral: Low-intensity, non-specific physical therapy interventions

Interventions

Low-intensity, task-specific physical therapy interventions BEHAVIORAL

Up to 30 1-hr sessions of training focused on walking trying to achieve lower cardiovascular intensities

Low-intensity, task-specific physical therapy interventions

High-intensity, task-specific (i.e., walking) interventions BEHAVIORAL

Up to 30 1-hr sessions of training focused on walking trying to achieve higher cardiovascular intensities

High-intensity, task-specific (i.e., walking) interventions

High-intensity, non-specific physical therapy interventions BEHAVIORAL

Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve higher cardiovascular intensities

High-intensity, non-specific physical therapy interventions

Low-intensity, non-specific physical therapy interventions BEHAVIORAL

Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve lower cardiovascular intensities

Low-intensity, non-specific physical therapy interventions

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Northwestern University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

RECRUITING

Related Publications (9)

• Holleran CL, Straube DD, Kinnaird CR, Leddy AL, Hornby TG. Feasibility and potential efficacy of high-intensity stepping training in variable contexts in subacute and chronic stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):643-51. doi: 10.1177/1545968314521001. Epub 2014 Feb 10.

  PMID: 24515925 BACKGROUND

• Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.

  PMID: 26338433 BACKGROUND

• Leddy AL, Connolly M, Holleran CL, Hennessy PW, Woodward J, Arena RA, Roth EJ, Hornby TG. Alterations in Aerobic Exercise Performance and Gait Economy Following High-Intensity Dynamic Stepping Training in Persons With Subacute Stroke. J Neurol Phys Ther. 2016 Oct;40(4):239-48. doi: 10.1097/NPT.0000000000000147.

  PMID: 27632078 BACKGROUND

• Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.

  PMID: 31434543 BACKGROUND

• Moore JL, Roth EJ, Killian C, Hornby TG. Locomotor training improves daily stepping activity and gait efficiency in individuals poststroke who have reached a "plateau" in recovery. Stroke. 2010 Jan;41(1):129-35. doi: 10.1161/STROKEAHA.109.563247. Epub 2009 Nov 12.

  PMID: 19910547 BACKGROUND

• Lotter JK, Henderson CE, Plawecki A, Holthus ME, Lucas EH, Ardestani MM, Schmit BD, Hornby TG. Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2020 Jul;34(7):627-639. doi: 10.1177/1545968320927384. Epub 2020 Jun 1.

  PMID: 32476619 BACKGROUND

• Straube DD, Holleran CL, Kinnaird CR, Leddy AL, Hennessy PW, Hornby TG. Effects of dynamic stepping training on nonlocomotor tasks in individuals poststroke. Phys Ther. 2014 Jul;94(7):921-33. doi: 10.2522/ptj.20130544. Epub 2014 Mar 13.

  PMID: 24627428 BACKGROUND

• Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.

  PMID: 31884902 BACKGROUND

• Boyne P, Dunning K, Carl D, Gerson M, Khoury J, Rockwell B, Keeton G, Westover J, Williams A, McCarthy M, Kissela B. High-Intensity Interval Training and Moderate-Intensity Continuous Training in Ambulatory Chronic Stroke: Feasibility Study. Phys Ther. 2016 Oct;96(10):1533-1544. doi: 10.2522/ptj.20150277. Epub 2016 Apr 21.

  PMID: 27103222 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Walking; Methods

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Investigative Techniques

Study Officials

• George Hornby

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Hornby

CONTACT

317-329-2353; tghornby@iu.edu

Chris Henderson

CONTACT

317-329-2353; henderce@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors will be utilized at baseline, post-training and follow-up assessments.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Variable Intensive Early Walking post-Stroke - 2 (VIEWS-2)

Model Details: 2X2 factorial design with primary independent variables of specificity of practice and intensity of practice during physical rehabilitation.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 14, 2023
• Study Start: January 11, 2023
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): October 15, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)