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StrokeLRCNCT05081713

Locomotor Recovery and Compensation Post-stroke (LRC)

A study testing high-intensity training focused on stepping in variable contexts in people with Stroke, run by Indiana University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
high-intensity training focused on stepping in variable contexts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
1 Sep 2021to 28 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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. \

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas G Hornby contact

3173292353

tghornby@Iu.edu

Chris Henderson contact

3173292353

henderce@iu.edu

United States1 site, 1 recruiting
  • Rehabilitation Hospital of Indiana

    Indianapolis, Indiana, 46254

    Thomas G Hornby, 312-350-8291, tghornby@Iu.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Recovery of locomotion is a primary goal of rehabilitation post-stroke and a major determinant of future morbidity and mortality. While substantial recovery is observed early post-stroke, recent evidence suggests the magnitude and time course of recovery is deterministic and based primarily on initial motor deficits. The "proportional recovery" rule suggests ~70% of neurological recovery (measured by the lower limb Fugl-Meyer Assessment - LL-FMA) is typically achieved and is not influenced by the dosage of therapy. These findings suggest the physical interventions applied to patients are of minimal importance to long-term recovery. That hypothesis conflicts directly with our recent efforts suggesting that maximizing the amount and intensity of task-specific (stepping) practice (high-intensity training; HIT) directly influences gains in locomotor function. Providing HIT at heart rates (HRs) greater than traditional aerobic paradigms (mean 110% baseline HRmax) is associated with gains in locomotor speed, which challenges the notion of "proportional recovery".

These conflicting hypotheses likely arise from differences in terminology and methodology used to characterize recovery post-stroke. First, the traditional measure of neurological recovery (LL-FMA) does not adequately characterize other impairments (strength, postural stability) that are more closely associated to locomotor function and are responsive to physical interventions. Second, despite gains in selected impairments, patients often utilize alternative (compensatory) movement patterns to accomplish locomotor tasks. More directly, locomotor recovery (i.e., speed/distance) is often accomplished using strategies employed prior to stroke and compensatory strategies, particularly in those with substantial impairments.

Our central hypothesis is that if changes in neurological recovery are deterministic, other measures of locomotor recovery or compensations may also be predictable. Our published data detail how HIT or conventional interventions can alter impairments and locomotor recovery, as well as changes in locomotor compensations. More directly, our data provide evidence that specific subgroups of patients demonstrate substantial compensations with improved recovery, whereas others reveal limited changes despite similar interventions. Data that detail the progression of neurological recovery, locomotor recovery, and locomotor compensations throughout the subacute to chronic phase post-stroke and their responsiveness to HIT is uncertain. Similar to upper limb recovery algorithms, predictions of mobility outcomes could provide valuable information to clinicians who make decisions regarding patient's prognosis, including whether patients will be able to walk with or without assistance or at certain speeds, and what compensatory strategies they may require to ambulate independently (braces, devices or altered movement patterns). The overarching goal of this project is to examine the time course of neurological and locomotor recovery, and associated compensatory strategies, over the subacute to chronic stages post-stroke and their responsiveness to HIT.

Conditions
Stroke
Being tested
high-intensity training focused on stepping in variable contexts
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-intensity training focused on stepping in variable contextsBehavioural

    Also called HIT

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

Study groups in NCT05081713
Study groupRoleWhat they receive
Phase 1OtherObservational evaluations for 6 months followed by 3-4 months of high-intensity training (HIT)
Receives: Behavioral: high-intensity training focused on stepping in variable contexts
Phase 2OtherObservational evaluations for 1 month followed by 3-4 months of high-intensity training (HIT)
Receives: Behavioral: high-intensity training focused on stepping in variable contexts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait speed

    Walking speed over 6 m

    Measured: 15 days post-stroke

  2. Gait speed

    Walking speed over 6 m

    Measured: 1 month

  3. Gait speed

    Walking speed over 6 m

    Measured: 2 months,

  4. Gait speed

    Walking speed over 6 m

    Measured: 4 months,

  5. Gait speed

    Walking speed over 6 m

    Measured: 6 months,

  6. Gait speed

    Walking speed over 6 m

    Measured: 9 months,

  7. Gait speed

    Walking speed over 6 m

    Measured: 12 months

  8. Walking distance

    Distance covered over 6 min

    Measured: 15 days post-stroke,

  9. Walking distance

    Distance covered over 6 min

    Measured: 1 month,

  10. Walking distance

    Distance covered over 6 min

    Measured: 2 months,

  11. Walking distance

    Distance covered over 6 min

    Measured: 4 months,

  12. Walking distance

    Distance covered over 6 min

    Measured: 6 months,

  13. Walking distance

    Distance covered over 6 min

    Measured: 9 months,

  14. Walking distance

    Distance covered over 6 min

    Measured: 12 months

Secondary outcomes (1)
  1. peak knee angle

    peak knee angle during swing phase

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study start1 Sep 2021
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
two separate longitudinal observational studies with interventions at different phases (duration) of recovery post-stroke
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05081713
Sponsor's protocol ID
IU2011618233
Other IDs
1R01NS118009
Acronym
LRC
Status last verified
Mar 2026
First submitted
24 Sep 2021
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data available upon reasonable request

Questions about this trial

What is this clinical trial studying?

A study testing high-intensity training focused on stepping in variable contexts in people with Stroke, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas G Hornby (3173292353, tghornby@Iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait speed (time frame: 15 days post-stroke). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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