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Fall Recovery Training for Individuals With Chronic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fall-recovery training
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must be 18 years or older
  • Participants must have had a single stroke of non-cerebellar origin

Exclusion Criteria:

  • More than one stroke
  • Unable to walk one block without stopping or using a walking aid, such as a cane
  • Acute illness at the time of functional assessment or training
  • Body mass greater than 136 kg (300 lbs)
  • Lower extremity joint replacement or shoulder joint replacement within a year prior to participation
  • Dementia
  • Parkinson's disease
  • A history of back surgery
  • A history of neck surgery
  • More than one occurrence of back or neck pain in the month prior to participation
  • Current back or neck pain at the time of participant enrollment
  • Bulging vertebral discs
  • Spine, hip, or lower extremity fracture within a year prior to participation
  • Open lesions on the lower extremity
  • Insulin-dependent diabetes
  • Use of a pacemaker
  • Use of an ostomy pouch
  • Pregnancy
  • Osteoporosis
  • Doctor recommendation to avoid moderate physical activity or exercise
  • Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training or introduces a confounding factor on the study, at the discretion of the clinician or study staff

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention Group

    Arm Description

    This group will receive up to six sessions of fall-recovery training over the course of 2-3 weeks.

    Outcomes

    Primary Outcome Measures

    Disturbance magnitude
    The highest disturbance magnitude from which a successful fall-recovery resulted on the first and last training sessions

    Secondary Outcome Measures

    Step length
    The length of the initial recovery step in response to the highest disturbance magnitude common to the first and last training sessions
    Trunk rotation
    The maximum trunk rotation angle in response to the highest disturbance magnitude common to the first and last training sessions

    Full Information

    First Posted
    August 16, 2018
    Last Updated
    September 16, 2019
    Sponsor
    University of Delaware
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03638089
    Brief Title
    Fall Recovery Training for Individuals With Chronic Stroke
    Official Title
    Fall Recovery Training for Individuals With Chronic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 11, 2015 (Actual)
    Primary Completion Date
    July 7, 2019 (Actual)
    Study Completion Date
    July 7, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Delaware

    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 purpose of this study is to quantify how fall-recovery training improves the fall-recovery response of individuals with chronic stroke. Up to 20 participants with chronic stroke will be recruited from the community. Over six laboratory visits, participants will undergo sessions of fall-recovery training. Each session is comprised of simulated trips and slips as participants stand on a computer-controlled treadmill. Trip-recovery training consists of treadmill-delivered disturbances that induce a forward fall. Slip-recovery training consists of a treadmill-delivered disturbances that induce a backward fall. Separate progressions focus on initial steps with the left and right limbs. The training intensity, as determined by the disturbance magnitude, is progressive and dependent on participant performance. Step length and maximum trunk angle will be calculated. The hypothesis is that, with practice, participants will recover from larger perturbations, and they will increase step length and reduce trunk rotation during fall recoveries.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    This group will receive up to six sessions of fall-recovery training over the course of 2-3 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Fall-recovery training
    Intervention Description
    Participants practice recovering from simulated, treadmill-induced slips and trips.
    Primary Outcome Measure Information:
    Title
    Disturbance magnitude
    Description
    The highest disturbance magnitude from which a successful fall-recovery resulted on the first and last training sessions
    Time Frame
    2-3 weeks (first to last training session)
    Secondary Outcome Measure Information:
    Title
    Step length
    Description
    The length of the initial recovery step in response to the highest disturbance magnitude common to the first and last training sessions
    Time Frame
    2-3 weeks (first to last training session)
    Title
    Trunk rotation
    Description
    The maximum trunk rotation angle in response to the highest disturbance magnitude common to the first and last training sessions
    Time Frame
    2-3 weeks (first to last training session)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must be 18 years or older Participants must have had a single stroke of non-cerebellar origin Exclusion Criteria: More than one stroke Unable to walk one block without stopping or using a walking aid, such as a cane Acute illness at the time of functional assessment or training Body mass greater than 136 kg (300 lbs) Lower extremity joint replacement or shoulder joint replacement within a year prior to participation Dementia Parkinson's disease A history of back surgery A history of neck surgery More than one occurrence of back or neck pain in the month prior to participation Current back or neck pain at the time of participant enrollment Bulging vertebral discs Spine, hip, or lower extremity fracture within a year prior to participation Open lesions on the lower extremity Insulin-dependent diabetes Use of a pacemaker Use of an ostomy pouch Pregnancy Osteoporosis Doctor recommendation to avoid moderate physical activity or exercise Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training or introduces a confounding factor on the study, at the discretion of the clinician or study staff

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31128598
    Citation
    Pigman J, Reisman DS, Pohlig RT, Wright TR, Crenshaw JR. The development and feasibility of treadmill-induced fall recovery training applied to individuals with chronic stroke. BMC Neurol. 2019 May 25;19(1):102. doi: 10.1186/s12883-019-1320-8.
    Results Reference
    derived

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    Fall Recovery Training for Individuals With Chronic Stroke

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