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Sit-to-stand With Feedback in SCI Patients

Primary Purpose

Injuries, Spinal Cord

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

About this trial

This is an interventional other trial for Injuries, Spinal Cord focused on measuring feedback

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ambulatory spinal cord injury patients

Exclusion Criteria:

  • Deformity of musculoskeletal system

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Feedback

    No feedback

    Arm Description

    Subjects will be trained using the sit-to-stand weight-taking machine. Prior to the training, subjects sit in a standard sitting position. Then they will be instructed to take most of their body-weight onto the legs while they standing up where the light bars will be gradually lightened from the red, yellow and green zones according to the level of LLL. Then they stand up, hold a standing position for 3-5 seconds and sit-down with always maximize their body-weight onto their legs during performing the task in which the green zone will always be lightened.

    Subjects will be trained using the same instruction and protocol as the experimental group, but without the provision of external feedback.

    Outcomes

    Primary Outcome Measures

    10MWT
    walking speed test

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2016
    Last Updated
    November 3, 2018
    Sponsor
    Khon Kaen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02913911
    Brief Title
    Sit-to-stand With Feedback in SCI Patients
    Official Title
    The Provision of External Feedback During Sit-to-stand in Ambulatory Patients With Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    August 2017 (Actual)
    Study Completion Date
    July 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
    Does the utility of external feedback in terms of goal-directed LLL approach during STS training immediately improve functional ability relating to walking in ambulatory patients with SCI? Does the utility of LLL feedback improve functional ability relating to walking in ambulatory patients with SCI after 2-week training?
    Detailed Description
    To compare immediate effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI To compare 2 weeks effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injuries, Spinal Cord
    Keywords
    feedback

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Feedback
    Arm Type
    Experimental
    Arm Description
    Subjects will be trained using the sit-to-stand weight-taking machine. Prior to the training, subjects sit in a standard sitting position. Then they will be instructed to take most of their body-weight onto the legs while they standing up where the light bars will be gradually lightened from the red, yellow and green zones according to the level of LLL. Then they stand up, hold a standing position for 3-5 seconds and sit-down with always maximize their body-weight onto their legs during performing the task in which the green zone will always be lightened.
    Arm Title
    No feedback
    Arm Type
    Sham Comparator
    Arm Description
    Subjects will be trained using the same instruction and protocol as the experimental group, but without the provision of external feedback.
    Intervention Type
    Other
    Intervention Name(s)
    feedback
    Intervention Description
    Sit to stand training with external feedback
    Primary Outcome Measure Information:
    Title
    10MWT
    Description
    walking speed test
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ambulatory spinal cord injury patients Exclusion Criteria: Deformity of musculoskeletal system
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sugalya Amatachaya, Ph.D.
    Organizational Affiliation
    School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Sit-to-stand With Feedback in SCI Patients

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