NCT05454007

Brief Summary

The purpose of this proposal is to use novel video-based movement tracking technology to measure gait quality after stroke - in the home. Current rehabilitation practice assesses walking in the highly controlled 'ideal' clinical environment. The implicit assumption by clinicians and researchers is that the way people walk in the clinic (their best capacity) reflects the way they walk in the real-world (true performance). With advances in computer vision and development of pose estimation algorithms, it is now possible to directly measure how people are walking in their homes. It is critical that researchers apply this technology to examine the basic assumptions that underlie current rehabilitation practice. Here, a video-based pose estimation workflow will be used to 1) contrast the gait patterns of persons post-stroke as observed in-clinical vs. in-home settings, and 2) map the rate of deterioration of clinically-derived walking improvements, in the home. This methodology has been used to accurately measure gait kinematics in people with stroke as they walk in laboratory, however this study now seeks to use these methods to record people with stroke as they walk in their natural home environments. The ultimate outcome of this project will not only be freely-available video-based workflow modified for home-based gait assessments, but also preliminary data revealing how people with stroke walk in the real world.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2022

Typical duration 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

First Submitted

Initial submission to the registry

June 21, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 25, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

June 21, 2022

Last Update Submit

April 25, 2024

Conditions

Keywords

gaitstep length asymmetrywalking

Outcome Measures

Primary Outcomes (3)

  • Change in step length symmetry

    The normalized difference between short step length and long step length; a spatial parameter (short step length - long step length / short step length + long step length) Will be compared across timepoints.

    In-clinic baseline (day 1), in-home baseline (day 1), during training (day 2), same day transfer assessment (day 2), 1-day transfer assessment (day 3), 3-day transfer assessment (day 5), 1-week transfer assessment (day 9)

  • Change in step time symmetry

    The difference between short step time and long step time; a temporal parameter (short step time- long step time) Will be compared across timepoints.

    In-clinic baseline (day 1), in-home baseline (day 1), during training (day 2), same day transfer assessment (day 2), 1-day transfer assessment (day 3), 3-day transfer assessment (day 5), 1-week transfer assessment (day 9)

  • Change in self selected gait speed

    The speed at which a participant is walking (meters/second) Will be compared across timepoints.

    In-clinic baseline (day 1), in-home baseline (day 1), during training (day 2), same day transfer assessment (day 2), 1-day transfer assessment (day 3), 3-day transfer assessment (day 5), 1-week transfer assessment (day 9)

Other Outcomes (4)

  • Stroke self-efficacy questionnaire

    Measured once, during the first session which takes place on a single day.

  • Home environment

    Measured once, during the first session which takes place on a single day.

  • Depression

    Measured once, during the first session which takes place on a single day.

  • +1 more other outcomes

Study Arms (1)

Individuals with Stroke

EXPERIMENTAL

In this single group, proof-of-principle design, all eligible participants will be assigned to a single group. These are individuals with stroke who meet inclusion and exclusion criteria. They will each undergo the same assessments and participate in a single walking training session.

Behavioral: Step length asymmetry training

Interventions

Participants will engage in four, five-minute periods of step symmetry training during session 2. This training uses established sensorimotor adaptation-based methods (e.g. split-belt treadmill walking, walking with unilateral leg weighting) to elicit motor aftereffects of more equal step lengths. Two minute sitting rest breaks will be given between training blocks or at the participant's request. A video recording will be taken of the first and final two minutes of training.

Individuals with Stroke

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke \>6 months prior
  • hemiparetic gait pattern with step length difference of 4cm or greater
  • able to ambulate whiteout physical assistance from another person (use of an assistive device are acceptable), gait speed \>/= 0.2m/s
  • normal or corrected-to-normal vision

You may not qualify if:

  • neurological condition other than stroke
  • aphasia limiting comprehension of task instructions pregnancy
  • uncontrolled hypertension (\> 150/90 mmHg at rest)
  • dementia, cognitive impairments, or psychiatric disorders limiting the ability to provide informed consent
  • epilepsy
  • orthopedic or pain conditions limiting walking
  • concurrent engagement in physical therapy or other research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University of Health Sciences

Lebanon, Oregon, 97355, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kendra Cherry-Allen, PhD, PT, DPT

    Western University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kendra M Cherry-Allen, PhD, PT,DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 21, 2022

First Posted

July 12, 2022

Study Start

August 25, 2022

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

De-identified data will be curated and deposited to appropriate public repositories whenever applicable. All behavioral data will be made available per reasonable request to the PI and all software will be made available on our GitHub archive.

Shared Documents
ANALYTIC CODE
Time Frame
Software will be posted to GitHub repository upon the conclusion of the study and will remain open access and freely available indefinitely.
Access Criteria
De-identified data will be curated and deposited to appropriate public repositories whenever applicable. All behavioral data will be made available per reasonable request to the PI and all software will be made available on our GitHub archive.

Locations