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Biomechanical Gait Analysis in Patients Post-Stroke

Primary Purpose

CVA (Cerebrovascular Accident), Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Body Weight Support Gait Training
Traditional Gait Training
Sponsored by
Florida Gulf Coast University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CVA (Cerebrovascular Accident) focused on measuring Body Weight Support

Eligibility Criteria

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

Inclusion Criteria:

  • Current in-patient in acute care for Cerebrovascular accident (CVA),
  • Unilateral CVA affecting at least the lower limb, and
  • Medically stable as determined by the rehabilitation physician.

Exclusion Criteria:

  • Previous (more than 1) CVA with residual lower limb deficit, and
  • Any lower extremity pathology on the affected side other than the effects of the CVA.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Traditional Gait Training

    Body Weight Support Training

    Arm Description

    The Traditional Gait Training group will receive gait training as presently performed without additional modalities.

    The Body Weight Support group will received body weight support gait training in lieu of traditional gait training.

    Outcomes

    Primary Outcome Measures

    Gait Speed
    Velocity of center of mass of the participant.
    Step Length
    Difference in position between the feet at heel strike, in the direction of forward motion.
    Step Width
    Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.
    Step Asymmetry
    The ratio of the difference of left and right step length over the stride length.

    Secondary Outcome Measures

    Gait Units
    Measure of the quantity of therapy received during the duration of care.
    Functional Independence Measure (FIM)
    A 17 items survey of patient independence in 2 domains, motor and cognition. It is used as a basic indicator of patient disability.
    Length of Stay
    Total duration of care at the acute rehabilitation facility.

    Full Information

    First Posted
    May 4, 2018
    Last Updated
    July 18, 2018
    Sponsor
    Florida Gulf Coast University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03602313
    Brief Title
    Biomechanical Gait Analysis in Patients Post-Stroke
    Official Title
    Biomechanical Gait Analysis in Patients Post-Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 6, 2011 (Actual)
    Primary Completion Date
    September 17, 2015 (Actual)
    Study Completion Date
    September 17, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Florida Gulf Coast University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Gait analysis is used to determine which of the two groups achieved gait parameters most similar to the normal gait of an age-matched population.
    Detailed Description
    Potential participants are identified upon admission to acute care post cerebrovascular accident (CVA) and screened for inclusion. Informed consent is obtained from the patient and/or designee. Demographic information is obtained from the medical record, the patient and/or designee by the clinical coordinator. The participant is randomized into traditional gait training group or body weight support (BWS) group. The participant receives the required amount of physical therapy as directed by clinicians at the acute care facility and accrediting agencies. The traditional gait training group will receive gait training as presently performed without additional modalities. The BWS group will received BWS gait training in lieu of traditional gait training. Participants will be treated in in-patient rehabilitation for a duration as determined by the clinical team; thus, the overall duration of care may be variable between participants. Time spent in gait training activities for both groups will be tracked by both service unit and by time (minutes). Within 48 hours of discharge from the acute care facility, the participant will be transported to a separate site for kinematic gait analysis using a marker based motion capture system. The procedure for gait analysis is as follows: Investigators will place reflective markers on the following areas using non-latex adhesive tape: top of the shoulders, bony part of the pelvis on the front and back, hips, front of the thighs, outside of the knees, front of the shins, outside of the ankles, first and fifth toes, and back of each heel. The participant will walk across the room in the gait analysis lab no more than 20 times at his/her choice of pace while the camera system records gait parameters and kinematics. He/she will be allowed to rest as needed during the data collection. The reflective markers and adhesive tape will be removed and the participant thanked for his/her participation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CVA (Cerebrovascular Accident), Stroke
    Keywords
    Body Weight Support

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were randomly assigned to 1 of 2 groups for the duration of the study.
    Masking
    Investigator
    Masking Description
    Investigators were blinded to the study intervention. Data collection was performed at a separate location than the primary intervention.
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Traditional Gait Training
    Arm Type
    Active Comparator
    Arm Description
    The Traditional Gait Training group will receive gait training as presently performed without additional modalities.
    Arm Title
    Body Weight Support Training
    Arm Type
    Experimental
    Arm Description
    The Body Weight Support group will received body weight support gait training in lieu of traditional gait training.
    Intervention Type
    Device
    Intervention Name(s)
    Body Weight Support Gait Training
    Other Intervention Name(s)
    BSWTT, LiteGait
    Intervention Type
    Other
    Intervention Name(s)
    Traditional Gait Training
    Other Intervention Name(s)
    Overground
    Primary Outcome Measure Information:
    Title
    Gait Speed
    Description
    Velocity of center of mass of the participant.
    Time Frame
    Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
    Title
    Step Length
    Description
    Difference in position between the feet at heel strike, in the direction of forward motion.
    Time Frame
    Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
    Title
    Step Width
    Description
    Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.
    Time Frame
    Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
    Title
    Step Asymmetry
    Description
    The ratio of the difference of left and right step length over the stride length.
    Time Frame
    Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
    Secondary Outcome Measure Information:
    Title
    Gait Units
    Description
    Measure of the quantity of therapy received during the duration of care.
    Time Frame
    Measured at discharge, approximately 21 days
    Title
    Functional Independence Measure (FIM)
    Description
    A 17 items survey of patient independence in 2 domains, motor and cognition. It is used as a basic indicator of patient disability.
    Time Frame
    Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days
    Title
    Length of Stay
    Description
    Total duration of care at the acute rehabilitation facility.
    Time Frame
    Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Current in-patient in acute care for Cerebrovascular accident (CVA), Unilateral CVA affecting at least the lower limb, and Medically stable as determined by the rehabilitation physician. Exclusion Criteria: Previous (more than 1) CVA with residual lower limb deficit, and Any lower extremity pathology on the affected side other than the effects of the CVA.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Derek J Lura, PhD
    Organizational Affiliation
    Florida Gulf Coast University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Biomechanical Gait Analysis in Patients Post-Stroke

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