search
Back to results

Effects of Trunk Stabilization Training Device on Balance Ability for Stroke Patients

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trunk stabilization training device
Conventional rehabilitation
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring trunk stabilization training

Eligibility Criteria

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

Inclusion Criteria:

  • Stroke patients 40 years or older (within 2 years of onset)
  • Those who have no problems with visual function in conducting and conducting clinical trials
  • Patients who are found to have decreased balance ability after stroke (BBS score is 21-40 points)
  • Those who do not have orthopedic diseases in both lower limbs
  • Subjects with cognitive functions capable of fulfilling and carrying out instructions
  • Those who voluntarily consent to the clinical trial

Exclusion Criteria:

  • Subjects with intellectual disabilities to the extent that they are unable to perform instructions
  • Subjects taking drugs that may affect the study
  • Subjects with skin and musculoskeletal abnormalities for which the device cannot be worn
  • Patients with neurological disorders other than stroke and other disorders that may affect balance
  • Other subjects who are judged to be unsuitable for this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Trunk stabilization training device

    Conventional rehabilitation

    Arm Description

    Participants will receive conventional rehabilitation and use trunk stabilization training device 30min each daily, 20 times for 4weeks.

    Participants will receive conventional rehabilitation 60min daily, 20times for 4weeks.

    Outcomes

    Primary Outcome Measures

    Change of Berg Balance Scale
    The Berg Balance Scale(BBS) is the quantified cutoff values for the four basic gait-related activities of stroke patients. It consists of a total of 14 items, and each item is divided into 5 levels, ranging from 0 to 4 points, with a total score of 56 points. Interpretation of exercise state according to score is 0-20: Wheelchair bound. 21-40: Walking with assistance. 41-56: independent.

    Secondary Outcome Measures

    Timed Up and Go test
    The Timed Up and Go test(TUG) starts with sitting in a chair and measures the time it takes to get up and walk 3 meters back to sitting on the chair.
    Functional Ambulation Category
    The Functional Ambulation Category(FAC) is a 7-point scale to evaluate the gait and mobility of patients with nervous and musculoskeletal injury. A higher score is interpreted as having higher independence of walking, and a score of 3 or less is considered difficult to move independently. It is a tool to evaluate not only balance ability but also actual mobility ability.
    Korean version of Modified Barthel Index
    The Korean version of Modified Barthel Index(K-MBI) is a tool to evaluate the patient's level of independence in daily living activities, including basic daily living activities and instrumental daily living activities. It consists of 5 to 15 points depending on the item, and the perfect score is 100 points. The higher the score, the higher the patient's level of independence from daily activities is considered.
    Fugl-Meyer Assessment(L/E)
    The Fugl-Meyer Assessment(FMA)(L/E) is an exercise ability scale to evaluate the motor function of stroke patients, and it is a tool to evaluate motor function of the healthy and injured upper and lower limbs. Each exercise item is evaluated on a 2-point scale and 3-point scale, with a perfect score of 100. In this study, lower limb evaluation items are implemented.
    Trunk Impairment Scale
    The Trunk Impairment Scale(TIS) is for the motor impairment of the trunk of a stroke patient. As an optimal test method, it measures static and dynamic balance and coordination between the body in a sitting position. There are a total of 17 items with 3 items for static balance ability in a sitting position, 10 items for dynamic balance ability, and 4 items for trunk coordination, and minimum 0 to maximum 23 points.

    Full Information

    First Posted
    January 31, 2021
    Last Updated
    February 14, 2021
    Sponsor
    Pusan National University Yangsan Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04745481
    Brief Title
    Effects of Trunk Stabilization Training Device on Balance Ability for Stroke Patients
    Official Title
    Effectiveness Evaluation of Trunk Stabilization Training Using Balance Pro(SBT-330) for Stroke Patients With Reduced Balance Ability
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 22, 2021 (Anticipated)
    Primary Completion Date
    March 15, 2021 (Anticipated)
    Study Completion Date
    February 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University Yangsan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the effectiveness of Balance pro(SBT-330:trunk stabilization training device) for stroke patients reduced balance ability
    Detailed Description
    after being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. Subjects who pass the screening test will randomize in a 1:1 ratio to experimental group(conventional rehabilitation + trunk stabilization training device, 30min each, 20days) or control group(conventional rehabilitation + conventional rehabilitation, 30min each, 20days). And then, They receive a registration number within 7 days and proceed with the pre-intervention test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    trunk stabilization training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Trunk stabilization training device
    Arm Type
    Experimental
    Arm Description
    Participants will receive conventional rehabilitation and use trunk stabilization training device 30min each daily, 20 times for 4weeks.
    Arm Title
    Conventional rehabilitation
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive conventional rehabilitation 60min daily, 20times for 4weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Trunk stabilization training device
    Other Intervention Name(s)
    Balance Pro(SBT-330)
    Intervention Description
    Conventional rehabilitation 30min daily, 20times 4weeks +Trunk stabilization training device 30min daily, 20time 4weeks
    Intervention Type
    Device
    Intervention Name(s)
    Conventional rehabilitation
    Other Intervention Name(s)
    Ergometer, Stepper
    Intervention Description
    Conventional rehabilitation 30min daily, 20times 4weeks +Conventional rehabilitation 30min daily, 20times 4weeks
    Primary Outcome Measure Information:
    Title
    Change of Berg Balance Scale
    Description
    The Berg Balance Scale(BBS) is the quantified cutoff values for the four basic gait-related activities of stroke patients. It consists of a total of 14 items, and each item is divided into 5 levels, ranging from 0 to 4 points, with a total score of 56 points. Interpretation of exercise state according to score is 0-20: Wheelchair bound. 21-40: Walking with assistance. 41-56: independent.
    Time Frame
    Change from baseline Berg Balance Scale at week 4
    Secondary Outcome Measure Information:
    Title
    Timed Up and Go test
    Description
    The Timed Up and Go test(TUG) starts with sitting in a chair and measures the time it takes to get up and walk 3 meters back to sitting on the chair.
    Time Frame
    baseline and week 4
    Title
    Functional Ambulation Category
    Description
    The Functional Ambulation Category(FAC) is a 7-point scale to evaluate the gait and mobility of patients with nervous and musculoskeletal injury. A higher score is interpreted as having higher independence of walking, and a score of 3 or less is considered difficult to move independently. It is a tool to evaluate not only balance ability but also actual mobility ability.
    Time Frame
    baseline and week 4
    Title
    Korean version of Modified Barthel Index
    Description
    The Korean version of Modified Barthel Index(K-MBI) is a tool to evaluate the patient's level of independence in daily living activities, including basic daily living activities and instrumental daily living activities. It consists of 5 to 15 points depending on the item, and the perfect score is 100 points. The higher the score, the higher the patient's level of independence from daily activities is considered.
    Time Frame
    baseline and week 4
    Title
    Fugl-Meyer Assessment(L/E)
    Description
    The Fugl-Meyer Assessment(FMA)(L/E) is an exercise ability scale to evaluate the motor function of stroke patients, and it is a tool to evaluate motor function of the healthy and injured upper and lower limbs. Each exercise item is evaluated on a 2-point scale and 3-point scale, with a perfect score of 100. In this study, lower limb evaluation items are implemented.
    Time Frame
    baseline and week 4
    Title
    Trunk Impairment Scale
    Description
    The Trunk Impairment Scale(TIS) is for the motor impairment of the trunk of a stroke patient. As an optimal test method, it measures static and dynamic balance and coordination between the body in a sitting position. There are a total of 17 items with 3 items for static balance ability in a sitting position, 10 items for dynamic balance ability, and 4 items for trunk coordination, and minimum 0 to maximum 23 points.
    Time Frame
    baseline and week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stroke patients 40 years or older (within 2 years of onset) Those who have no problems with visual function in conducting and conducting clinical trials Patients who are found to have decreased balance ability after stroke (BBS score is 21-40 points) Those who do not have orthopedic diseases in both lower limbs Subjects with cognitive functions capable of fulfilling and carrying out instructions Those who voluntarily consent to the clinical trial Exclusion Criteria: Subjects with intellectual disabilities to the extent that they are unable to perform instructions Subjects taking drugs that may affect the study Subjects with skin and musculoskeletal abnormalities for which the device cannot be worn Patients with neurological disorders other than stroke and other disorders that may affect balance Other subjects who are judged to be unsuitable for this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yong-il Shin, PhD
    Phone
    082+01065350310
    Email
    rm01shin@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yong-il Shin, PhD
    Organizational Affiliation
    Pusan National University Yangsan Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32282572
    Citation
    Min JH, Seong HY, Ko SH, Jo WR, Sohn HJ, Ahn YH, Son JH, Seo HY, Son YR, Mun SJ, Ko MH, Shin YI. Effects of trunk stabilization training robot on postural control and gait in patients with chronic stroke: a randomized controlled trial. Int J Rehabil Res. 2020 Jun;43(2):159-166. doi: 10.1097/MRR.0000000000000399.
    Results Reference
    background
    PubMed Identifier
    30852865
    Citation
    Chung SH, Kim JH, Yong SY, Lee YH, Park JM, Kim SH, Lee HC. Effect of Task-Specific Lower Extremity Training on Cognitive and Gait Function in Stroke Patients: A Prospective Randomized Controlled Trial. Ann Rehabil Med. 2019 Feb;43(1):1-10. doi: 10.5535/arm.2019.43.1.1. Epub 2019 Feb 28.
    Results Reference
    background

    Learn more about this trial

    Effects of Trunk Stabilization Training Device on Balance Ability for Stroke Patients

    We'll reach out to this number within 24 hrs