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Stepping Training Using Feedback in Stroke

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stepping training with feedback
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Feedback, Physical Therapy

Eligibility Criteria

45 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects are independent ambulatory patients with first stroke episode with the age at least 45-74 years old,
  • subacute (post-stroke time < 6 months) or chronic (post-stroke time ≥ 6 months) stroke
  • Independent walking at least 10 meters with or without a walking device
  • Able to follow verbal command used in this study

Exclusion Criteria:

  • The subjects who have other medical conditions that might affect participation in the study such as uncontrolled underlying diseases (i.e. hypertension, heart disease, thyroid, etc.), deformity in the lower extremities, pain more than 5 out of 10 on a visual analog scale, legally blind or had a history of visual deficits that were unable to be corrected by glasses or contact lens, have a color blindness and inability to communicate or follow the commands used in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Stepping training with feedback

    Stepping training without feedback

    Arm Description

    Subjects stand in a step standing position with placing the affected leg on the load cells of the VWTM and the non-affected leg slightly backward outside the load cells, look forward to light bars of the displayed section which will be set at their eye level. Then subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can. Subjects repetitively practice the task for 30 minutes with a period of sufficient rest as required.

    Subjects will be trained and instructed the same as the experimental group but without using the displayed section, for approximately 30 minutes/day (excluding rest periods), 5 days/week, for 4 week. Then, every subject will be trained to walk overground with or without a walking device for 10 minutes in order to promote transferability of the part-task practice to the whole/target task. Subjects still receive routine treatments from other rehabilitation professionals as needed during participation in the study.

    Outcomes

    Primary Outcome Measures

    10MWT
    Walking speed

    Secondary Outcome Measures

    6MWT
    Walking endurance
    TUGT
    Balance and walking ability
    Lower limb support ability
    % of bosy-weight on single leg during stepping

    Full Information

    First Posted
    September 22, 2016
    Last Updated
    March 8, 2019
    Sponsor
    Khon Kaen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02916797
    Brief Title
    Stepping Training Using Feedback in Stroke
    Official Title
    Effects of Stepping Training With and Without the Use of Visually Weight-taking Machine (VWTM) on Walking and Balance Ability in Patients With Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 10, 2016 (Actual)
    Primary Completion Date
    February 28, 2018 (Actual)
    Study Completion Date
    February 28, 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Are there differences in immediate effects of stepping training with and without the use of visually weight-taking machine (VWTM) on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke? Are there differences of 4-week stepping training with and without the use of VWTM on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke?
    Detailed Description
    To compare immediate effects of stepping training with or without the use of VWTM on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke. To compare effects of 4-week stepping training with or without the use of VWTM on variables relating to well-controlled walking and walking symmetry in patients with stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrovascular Accident
    Keywords
    Feedback, Physical Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stepping training with feedback
    Arm Type
    Experimental
    Arm Description
    Subjects stand in a step standing position with placing the affected leg on the load cells of the VWTM and the non-affected leg slightly backward outside the load cells, look forward to light bars of the displayed section which will be set at their eye level. Then subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can. Subjects repetitively practice the task for 30 minutes with a period of sufficient rest as required.
    Arm Title
    Stepping training without feedback
    Arm Type
    No Intervention
    Arm Description
    Subjects will be trained and instructed the same as the experimental group but without using the displayed section, for approximately 30 minutes/day (excluding rest periods), 5 days/week, for 4 week. Then, every subject will be trained to walk overground with or without a walking device for 10 minutes in order to promote transferability of the part-task practice to the whole/target task. Subjects still receive routine treatments from other rehabilitation professionals as needed during participation in the study.
    Intervention Type
    Other
    Intervention Name(s)
    Stepping training with feedback
    Intervention Description
    Stepping training with the use of external feedback. The subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can.
    Primary Outcome Measure Information:
    Title
    10MWT
    Description
    Walking speed
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    6MWT
    Description
    Walking endurance
    Time Frame
    4 weeks
    Title
    TUGT
    Description
    Balance and walking ability
    Time Frame
    4 weeks
    Title
    Lower limb support ability
    Description
    % of bosy-weight on single leg during stepping
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects are independent ambulatory patients with first stroke episode with the age at least 45-74 years old, subacute (post-stroke time < 6 months) or chronic (post-stroke time ≥ 6 months) stroke Independent walking at least 10 meters with or without a walking device Able to follow verbal command used in this study Exclusion Criteria: The subjects who have other medical conditions that might affect participation in the study such as uncontrolled underlying diseases (i.e. hypertension, heart disease, thyroid, etc.), deformity in the lower extremities, pain more than 5 out of 10 on a visual analog scale, legally blind or had a history of visual deficits that were unable to be corrected by glasses or contact lens, have a color blindness and inability to communicate or follow the commands used in this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sugalya Amatachay, Ph.D.
    Organizational Affiliation
    School of Physical Therapy,Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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