NCT05081713

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable stroke

Timeline
22mo left

Started Sep 2021

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Sep 2021Feb 2028

Study Start

First participant enrolled

September 1, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

6.5 years

First QC Date

September 24, 2021

Last Update Submit

March 3, 2026

Conditions

Stroke

Outcome Measures

Primary Outcomes (14)

  • Gait speed

    Walking speed over 6 m

    15 days post-stroke

  • Gait speed

    Walking speed over 6 m

    1 month

  • Gait speed

    Walking speed over 6 m

    2 months,

  • Gait speed

    Walking speed over 6 m

    4 months,

  • Gait speed

    Walking speed over 6 m

    6 months,

  • Gait speed

    Walking speed over 6 m

    9 months,

  • Gait speed

    Walking speed over 6 m

    12 months

  • Walking distance

    Distance covered over 6 min

    15 days post-stroke,

  • Walking distance

    Distance covered over 6 min

    1 month,

  • Walking distance

    Distance covered over 6 min

    2 months,

  • Walking distance

    Distance covered over 6 min

    4 months,

  • Walking distance

    Distance covered over 6 min

    6 months,

  • Walking distance

    Distance covered over 6 min

    9 months,

  • Walking distance

    Distance covered over 6 min

    12 months

Secondary Outcomes (1)

  • peak knee angle

    6 months

Study Arms (2)

Phase 1

OTHER

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

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)

Behavioral: high-intensity training focused on stepping in variable contexts

Interventions

high-intensity training focused on stepping in variable contextsBEHAVIORAL

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

Also known as: HIT
Phase 1Phase 2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. \\

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas G Hornby

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas G Hornby

CONTACT

3173292353tghornby@Iu.edu

Chris Henderson

CONTACT

3173292353henderce@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: two separate longitudinal observational studies with interventions at different phases (duration) of recovery post-stroke
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physical Medicine

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 18, 2021

Study Start

September 1, 2021

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2028

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified data available upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
after completion of study for 3 years

Locations

US(1)