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Locomotor Recovery and Compensation Post-stroke (LRC) (LRC)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high-intensity training focused on stepping in variable contexts
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Hospital of IndianaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Phase 1

Phase 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gait speed
Walking speed over 6 m
Gait speed
Walking speed over 6 m
Gait speed
Walking speed over 6 m
Gait speed
Walking speed over 6 m
Gait speed
Walking speed over 6 m
Gait speed
Walking speed over 6 m
Gait speed
Walking speed over 6 m
Walking distance
Distance covered over 6 min
Walking distance
Distance covered over 6 min
Walking distance
Distance covered over 6 min
Walking distance
Distance covered over 6 min
Walking distance
Distance covered over 6 min
Walking distance
Distance covered over 6 min
Walking distance
Distance covered over 6 min
Gait kinematics
peak hip, knee, ankle range of motion
Gait kinematics
peak hip, knee, ankle range of motion
Gait kinematics
peak hip, knee, ankle range of motion
Gait kinematics
peak hip, knee, ankle range of motion
Gait kinematics
peak hip, knee, ankle range of motion
Gait kinematics
peak hip, knee, ankle range of motion
Gait kinematics
peak hip, knee, ankle range of motion

Secondary Outcome Measures

Full Information

First Posted
September 24, 2021
Last Updated
July 31, 2023
Sponsor
Indiana University
Collaborators
Rehabilitation Hospital of Indiana, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05081713
Brief Title
Locomotor Recovery and Compensation Post-stroke (LRC)
Acronym
LRC
Official Title
Locomotor Recovery and Compensation Post-stroke (LRC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Rehabilitation Hospital of Indiana, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
two separate longitudinal observational studies with interventions at different phases (duration) of recovery post-stroke
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1
Arm Type
Other
Arm Description
Observational evaluations for 6 months followed by 3-4 months of high-intensity training (HIT)
Arm Title
Phase 2
Arm Type
Other
Arm Description
Observational evaluations for 1 month followed by 3-4 months of high-intensity training (HIT)
Intervention Type
Behavioral
Intervention Name(s)
high-intensity training focused on stepping in variable contexts
Other Intervention Name(s)
HIT
Intervention Description
Approximately 10 weeks (~30 sessions) of high-intensity training
Primary Outcome Measure Information:
Title
Gait speed
Description
Walking speed over 6 m
Time Frame
15 days post-stroke
Title
Gait speed
Description
Walking speed over 6 m
Time Frame
1 month
Title
Gait speed
Description
Walking speed over 6 m
Time Frame
2 months,
Title
Gait speed
Description
Walking speed over 6 m
Time Frame
4 months,
Title
Gait speed
Description
Walking speed over 6 m
Time Frame
6 months,
Title
Gait speed
Description
Walking speed over 6 m
Time Frame
9 months,
Title
Gait speed
Description
Walking speed over 6 m
Time Frame
12 months
Title
Walking distance
Description
Distance covered over 6 min
Time Frame
15 days post-stroke,
Title
Walking distance
Description
Distance covered over 6 min
Time Frame
1 month,
Title
Walking distance
Description
Distance covered over 6 min
Time Frame
2 months,
Title
Walking distance
Description
Distance covered over 6 min
Time Frame
4 months,
Title
Walking distance
Description
Distance covered over 6 min
Time Frame
6 months,
Title
Walking distance
Description
Distance covered over 6 min
Time Frame
9 months,
Title
Walking distance
Description
Distance covered over 6 min
Time Frame
12 months
Title
Gait kinematics
Description
peak hip, knee, ankle range of motion
Time Frame
15 days
Title
Gait kinematics
Description
peak hip, knee, ankle range of motion
Time Frame
1 month
Title
Gait kinematics
Description
peak hip, knee, ankle range of motion
Time Frame
2 months
Title
Gait kinematics
Description
peak hip, knee, ankle range of motion
Time Frame
4 months
Title
Gait kinematics
Description
peak hip, knee, ankle range of motion
Time Frame
6 months
Title
Gait kinematics
Description
peak hip, knee, ankle range of motion
Time Frame
9 months
Title
Gait kinematics
Description
peak hip, knee, ankle range of motion
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas G Hornby
Phone
3123508291
Email
tghornby@Iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G Hornby
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas G Hornby
Phone
312-350-8291
Email
tghornby@Iu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data available upon reasonable request
IPD Sharing Time Frame
after completion of study for 3 years

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Locomotor Recovery and Compensation Post-stroke (LRC)

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