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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-intensity, task-specific (i.e., walking) interventions
High-intensity, non-specific physical therapy interventions
Low-intensity, task-specific physical therapy interventions
Low-intensity, non-specific physical therapy interventions
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring acute, walking deficits

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 Exclusion Criteria: 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.

Sites / Locations

  • Rehabilitation Hospital of IndianaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

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

High-intensity, non-specific physical therapy interventions

Low-intensity, task-specific physical therapy interventions

Low-intensity, non-specific physical therapy interventions

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Changes in gait speed
Changes in gait speed over 6 m from baseline to post-training
Changes in 6 minute walk test
Changes in 6 min walk test from baseline to post-training

Secondary Outcome Measures

Changes in community mobility
Changes in daily stepping (steps/day) from baseline to post-training
Changes in measures of physical participation
Changes in Medical Outcomes Short Form -36 questions from baseline to post-training
Changes in gait biomechanics
Changes in gait biomechanics (spatiotemporal and joint kinematics and kinetics) from baseline to post-training
Changes in peak metabolic capacity (VO2peak) during peak treadmill speed
Changes in peak metabolic capacity (VO2peak) during peak treadmill speed from baseline to post-training
Changes in peak treadmill speed during the graded-exercise test
Changes in peak treadmill speed during the graded-exercise test from baseline to post-testing

Full Information

First Posted
February 6, 2023
Last Updated
July 31, 2023
Sponsor
Indiana University
Collaborators
Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05727930
Brief Title
Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)
Acronym
VIEWS-2
Official Title
Variable Intensive Early Walking Post-Stroke -2 (VIEWS-2)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The objective of this Phase II clinical trial is to identify how exercise training parameters, particularly the specificity and intensity of stepping practice, influence long-term mobility outcomes in patients with subacute stroke. Previous work indicates these variables can influence the efficacy of training interventions in individuals without neurological injury, with some data to support their utility in chronic stroke. However, studies that systematically assess the independent and combined effects of these principles in individuals early following stroke are sparse. This critical research gap impedes clinical translation, and current clinical practices remain adherent to traditional theories of rehabilitation, including lower intensity interventions focused on underlying impairments. Additional concerns of providing only high-intensity walking training revolve around the lack of attention toward movement quality will result in use of compensatory movement strategies that could be reinforced with repeated practice, or that other risks of cardiovascular events should preclude high-intensity training. Unfortunately, there is little data to support these hypotheses, and our studies suggest that application of these training parameters can strongly influence walking function, as well as improve underlying impairments and improve gait kinematics. Our approach is to characterize the effects of these training variables on recovery of locomotor function and quality, as well as changes in impairments and other mobility tasks in patients early post-stroke, in an effort to evaluate whether such training influences neurological recovery or whether patients utilize compensatory strategies. In this 2x2 factorial RCT design, Aim 1 of the study will characterize changes in mobility function associated with manipulation of specific and intensity of exercise interventions. We will evaluate functional measures of gait speed and endurance, spatiotemporal symmetry, as well as measures of cardiopulmonary fitness. We postulate that combined application of high-intensity, task specific stepping practice will result in significantly greater increases in locomotor measures as compared to lower intensity or non-specific training paradigms. In Aim 2, we will characterize the changes in impairments (strength) and other mobility tasks (balance, sit-to-stand transfers) to determine whether stepping intervention can mitigate the major impairments underlying post-stroke impairments. Quantitative measures of volitional strength will be the primary outcomes. In Aim 3, we will characterize changes in community mobility and quality of life, the later of which can inform us about cost-effectiveness. Overall, these results have potential implications on the delivery of effective exercise interventions in person with subacute stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
acute, walking deficits

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2X2 factorial design with primary independent variables of specificity of practice and intensity of practice during physical rehabilitation.
Masking
Outcomes Assessor
Masking Description
Blinded assessors will be utilized at baseline, post-training and follow-up assessments.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity, task-specific (i.e., walking) interventions
Arm Type
Experimental
Arm Description
30 1-hr sessions of walking training targeting higher cardiovascular intensities over approximately 2 months
Arm Title
High-intensity, non-specific physical therapy interventions
Arm Type
Active Comparator
Arm Description
30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting higher cardiovascular intensities over approximately 2 months
Arm Title
Low-intensity, task-specific physical therapy interventions
Arm Type
Active Comparator
Arm Description
30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months
Arm Title
Low-intensity, non-specific physical therapy interventions
Arm Type
Active Comparator
Arm Description
30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months
Intervention Type
Behavioral
Intervention Name(s)
High-intensity, task-specific (i.e., walking) interventions
Intervention Description
Up to 30 1-hr sessions of training focused on walking trying to achieve higher cardiovascular intensities
Intervention Type
Behavioral
Intervention Name(s)
High-intensity, non-specific physical therapy interventions
Intervention Description
Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve higher cardiovascular intensities
Intervention Type
Behavioral
Intervention Name(s)
Low-intensity, task-specific physical therapy interventions
Intervention Description
Up to 30 1-hr sessions of training focused on walking trying to achieve lower cardiovascular intensities
Intervention Type
Behavioral
Intervention Name(s)
Low-intensity, non-specific physical therapy interventions
Intervention Description
Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve lower cardiovascular intensities
Primary Outcome Measure Information:
Title
Changes in gait speed
Description
Changes in gait speed over 6 m from baseline to post-training
Time Frame
Approximately 8-10 weeks
Title
Changes in 6 minute walk test
Description
Changes in 6 min walk test from baseline to post-training
Time Frame
Approximately 8-10 weeks
Secondary Outcome Measure Information:
Title
Changes in community mobility
Description
Changes in daily stepping (steps/day) from baseline to post-training
Time Frame
Approximately 8-10 weeks
Title
Changes in measures of physical participation
Description
Changes in Medical Outcomes Short Form -36 questions from baseline to post-training
Time Frame
Approximately 8-10 weeks
Title
Changes in gait biomechanics
Description
Changes in gait biomechanics (spatiotemporal and joint kinematics and kinetics) from baseline to post-training
Time Frame
Approximately 8-10 weeks
Title
Changes in peak metabolic capacity (VO2peak) during peak treadmill speed
Description
Changes in peak metabolic capacity (VO2peak) during peak treadmill speed from baseline to post-training
Time Frame
Approximately 8-10 weeks
Title
Changes in peak treadmill speed during the graded-exercise test
Description
Changes in peak treadmill speed during the graded-exercise test from baseline to post-testing
Time Frame
Approximately 8-10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Hornby
Phone
317-329-2353
Email
tghornby@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Henderson
Phone
317-329-2353
Email
henderce@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Hornby
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Hornby
Phone
317-329-2353
Email
tghornby@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Currently Undecided
Citations:
PubMed Identifier
24515925
Citation
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.
Results Reference
background
PubMed Identifier
26338433
Citation
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.
Results Reference
background
PubMed Identifier
27632078
Citation
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.
Results Reference
background
PubMed Identifier
31434543
Citation
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.
Results Reference
background
PubMed Identifier
19910547
Citation
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.
Results Reference
background
PubMed Identifier
32476619
Citation
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.
Results Reference
background
PubMed Identifier
24627428
Citation
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.
Results Reference
background
PubMed Identifier
31884902
Citation
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.
Results Reference
background
PubMed Identifier
27103222
Citation
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.
Results Reference
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Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)

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