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

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05727930

Collaborator

Northwestern University (Other)

100

Enrollment

Location

Arms

71.7

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: High-intensity, task-specific (i.e., walking) interventions Behavioral: High-intensity, non-specific physical therapy interventions Behavioral: Low-intensity, task-specific physical therapy interventions Behavioral: Low-intensity, non-specific physical therapy interventions	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

Blinded assessors will be utilized at baseline, post-training and follow-up assessments.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-intensity, task-specific (i.e., walking) interventions 30 1-hr sessions of walking training targeting higher cardiovascular intensities over approximately 2 months	Behavioral: High-intensity, task-specific (i.e., walking) interventions Up to 30 1-hr sessions of training focused on walking trying to achieve higher cardiovascular intensities
Active Comparator: High-intensity, non-specific physical therapy interventions 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 Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve higher cardiovascular intensities
Active Comparator: Low-intensity, task-specific physical therapy interventions 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 Up to 30 1-hr sessions of training focused on walking trying to achieve lower cardiovascular intensities
Active Comparator: Low-intensity, non-specific physical therapy interventions 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 Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve lower cardiovascular intensities

Outcome Measures

Primary Outcome Measures

Changes in gait speed [Approximately 8-10 weeks]
Changes in gait speed over 6 m from baseline to post-training
Changes in 6 minute walk test [Approximately 8-10 weeks]
Changes in 6 min walk test from baseline to post-training

Secondary Outcome Measures

Changes in community mobility [Approximately 8-10 weeks]
Changes in daily stepping (steps/day) from baseline to post-training
Changes in measures of physical participation [Approximately 8-10 weeks]
Changes in Medical Outcomes Short Form -36 questions from baseline to post-training
Changes in gait biomechanics [Approximately 8-10 weeks]
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 [Approximately 8-10 weeks]
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 [Approximately 8-10 weeks]
Changes in peak treadmill speed during the graded-exercise test from baseline to post-testing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehabilitation Hospital of Indiana	Indianapolis	Indiana	United States	46254

Sponsors and Collaborators

Indiana University
Northwestern University

Investigators

Principal Investigator: George Hornby, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

George Hornby, Variable Intensive Early Walking post-Stroke - 2 (VIEWS-2), Indiana University

ClinicalTrials.gov Identifier:

NCT05727930

Other Study ID Numbers:

IU-16767

First Posted:

Feb 14, 2023

Last Update Posted:

Feb 14, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by George Hornby, Variable Intensive Early Walking post-Stroke - 2 (VIEWS-2), Indiana University

acute

walking deficits

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Feb 14, 2023