Recruiting

Locomotor Recovery

Sponsor:

Indiana University

Code:

NCT05081713

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

high-intensity training focused on stepping in variable contexts

Study Details

Brief summary:

The proposed research will characterize of the time course of neurological and locomotor recovery as well as development of compensatory strategies throughout sub-acute and chronic phases post stroke. In addition, we will also investigate the extent to which measures of recovery and compensation are malleable and can be altered with specific interventions in both the early and late stages post-stroke. Delineation of the time course of development and magnitude of patterns of recovery and compensation should result in alternative predictive "rules' regarding how patients early post-stroke could recovery functional and neurological function.

Conditions

Stroke

Study ID

NCT05081713

Start date

Sep 1, 2021

Status verified date

Mar, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • individuals early post-stroke (<15-30 days)
  • first ever stroke
  • unilateral hemiparesis
  • currently receiving inpatient rehabilitation
  • ability to follow 1-step commands
  • provision of informed consent
  • medical clearance from the rehabilitation physician to participate. \\

Exclusion criteria:

  • uncontrolled cardiovascular, metabolic or respiratory disease that limits exercise participation (e.g., congestive heart failure, resting blood pressure > 200/110 mmHg, uncontrolled diabetes, end-stage renal disease)
  • absolute criteria for termination of exercise testing during initial and repeated ECG testing during graded exercise testing using ACSM guidelines .
  • other orthopedic or neurological disorder that limited walking prior to stroke

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Phase 1

Observational evaluations for 6 months followed by 3-4 months of high-intensity training (HIT)

other: Phase 2

Observational evaluations for 1 month followed by 3-4 months of high-intensity training (HIT)

Interventions

high-intensity training focused on stepping in variable contexts

Approximately 10 weeks (\~30 sessions) of high-intensity training

Primary outcome measure

  • Gait speed [ Time Frame: 15 days post-stroke ]
  • Gait speed [ Time Frame: 1 month ]
  • Gait speed [ Time Frame: 2 months, ]
  • Gait speed [ Time Frame: 4 months, ]
  • Gait speed [ Time Frame: 6 months, ]
  • Gait speed [ Time Frame: 9 months, ]
  • Gait speed [ Time Frame: 12 months ]
  • Walking distance [ Time Frame: 15 days post-stroke, ]
  • Walking distance [ Time Frame: 1 month, ]
  • Walking distance [ Time Frame: 2 months, ]
  • Walking distance [ Time Frame: 4 months, ]
  • Walking distance [ Time Frame: 6 months, ]
  • Walking distance [ Time Frame: 9 months, ]
  • Walking distance [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Thomas G Hornby

3173292353tghornby@Iu.edu

Chris Henderson

3173292353henderce@iu.edu

Locations

Rehabilitation Hospital of Indiana

Recruiting

Indianapolis, Indiana, United States, 46254

Contacts

Thomas G Hornby

312-350-8291tghornby@Iu.edu

More Information

Sponsor

Indiana University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

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 2026-03-05.