Recruiting

VIEWS-2

Sponsor:

Indiana University

Code:

NCT05727930

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05727930

Start date

Jan 11, 2023

Status verified date

Mar, 2026

Completion date

Oct 15, 2028

Anticipated

Primary completion date

Oct 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

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

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

Interventions

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

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

Low-intensity, task-specific physical therapy interventions

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

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

Primary outcome measure

  • Changes in 6 minute walk test [ Time Frame: Approximately 8-10 weeks ]

Central Contacts and Locations

Central contacts

George Hornby

317-329-2353tghornby@iu.edu

Chris Henderson

317-329-2353henderce@iu.edu

Locations

Rehabilitation Hospital of Indiana

Recruiting

Indianapolis, Indiana, United States, 46254

Contacts

George Hornby

317-329-2353tghornby@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • acute
  • walking deficits

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-03-27.