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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
Thomas G Hornby, 312-350-8291, tghornby@Iu.edu
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 group | Role | What they receive |
|---|---|---|
| Phase 1 | Other | Observational 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 2 | Other | Observational 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.
Gait speed
Walking speed over 6 m
Measured: 15 days post-stroke
Gait speed
Walking speed over 6 m
Measured: 1 month
Gait speed
Walking speed over 6 m
Measured: 2 months,
Gait speed
Walking speed over 6 m
Measured: 4 months,
Gait speed
Walking speed over 6 m
Measured: 6 months,
Gait speed
Walking speed over 6 m
Measured: 9 months,
Gait speed
Walking speed over 6 m
Measured: 12 months
Walking distance
Distance covered over 6 min
Measured: 15 days post-stroke,
Walking distance
Distance covered over 6 min
Measured: 1 month,
Walking distance
Distance covered over 6 min
Measured: 2 months,
Walking distance
Distance covered over 6 min
Measured: 4 months,
Walking distance
Distance covered over 6 min
Measured: 6 months,
Walking distance
Distance covered over 6 min
Measured: 9 months,
Walking distance
Distance covered over 6 min
Measured: 12 months
Secondary outcomes (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.
- First posted18 Oct 2021
- Study start1 Sep 2021
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, George Hornby, Indiana University
- Investigators
- Thomas G Hornby, Principal investigator, Indiana University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Recovery and Compensation Post-stroke (LRC)
- ClinicalTrials.gov ID
- NCT05081713
- Acronym / sponsor ID
- LRC / IU2011618233
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two separate longitudinal observational studies with interventions at different phases (duration) of recovery post-stroke
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Other | Behavioral: high-intensity training focused on stepping in variable contextsObservational evaluations for 6 months followed by 3-4 months of high-intensity training (HIT) |
| Phase 2 | Other | Behavioral: high-intensity training focused on stepping in variable contextsObservational evaluations for 1 month followed by 3-4 months of high-intensity training (HIT) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- individuals early post-stroke (<15-30 days)
- first ever stroke
- unilateral hemiparesis
- currently receiving inpatient rehabilitation
- ability to follow 1-step commands
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-intensity training focused on stepping in variable contextsAlso: HITApproximately 10 weeks (~30 sessions) of high-intensity training | Behavioural | Phase 1, Phase 2 |
Primary outcome
Gait speed
Time frame: 15 days post-stroke
Walking speed over 6 m
Gait speed
Time frame: 1 month
Walking speed over 6 m
Gait speed
Time frame: 2 months,
Walking speed over 6 m
Gait speed
Time frame: 4 months,
Walking speed over 6 m
Gait speed
Time frame: 6 months,
Walking speed over 6 m
Gait speed
Time frame: 9 months,
Walking speed over 6 m
Gait speed
Time frame: 12 months
Walking speed over 6 m
Walking distance
Time frame: 15 days post-stroke,
Distance covered over 6 min
Walking distance
Time frame: 1 month,
Distance covered over 6 min
Walking distance
Time frame: 2 months,
Distance covered over 6 min
Walking distance
Time frame: 4 months,
Distance covered over 6 min
Walking distance
Time frame: 6 months,
Distance covered over 6 min
Walking distance
Time frame: 9 months,
Distance covered over 6 min
Walking distance
Time frame: 12 months
Distance covered over 6 min
1 secondary outcome
peak knee angle
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified data available upon reasonable request
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas G Hornby principal investigator
Indiana University
1 site in 1 country: see every site and its status.
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.