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

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ClinicalTrials.gov Identifier: NCT04745481
Recruitment Status : Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Yong-il Shin, Pusan National University Yangsan Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Stroke Device: Trunk stabilization training device Device: Conventional rehabilitation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness Evaluation of Trunk Stabilization Training Using Balance Pro(SBT-330) for Stroke Patients With Reduced Balance Ability
Estimated Study Start Date : February 22, 2021
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Trunk stabilization training device
Participants will receive conventional rehabilitation and use trunk stabilization training device 30min each daily, 20 times for 4weeks.
 Device: Trunk stabilization training device

Conventional rehabilitation 30min daily, 20times 4weeks

+Trunk stabilization training device 30min daily, 20time 4weeks

Other Name: Balance Pro(SBT-330)
Active Comparator: Conventional rehabilitation
Participants will receive conventional rehabilitation 60min daily, 20times for 4weeks.
 Device: Conventional rehabilitation

Conventional rehabilitation 30min daily, 20times 4weeks

+Conventional rehabilitation 30min daily, 20times 4weeks

Other Name: Ergometer, Stepper


Outcome Measures
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Primary Outcome Measures :
  1. Change of Berg Balance Scale [ Time Frame: Change from baseline Berg Balance Scale at week 4 ]
    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 :
  1. Timed Up and Go test [ Time Frame: baseline and week 4 ]
    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.

  2. Functional Ambulation Category [ Time Frame: baseline and week 4 ]
    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.

  3. Korean version of Modified Barthel Index [ Time Frame: baseline and week 4 ]
    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.

  4. Fugl-Meyer Assessment(L/E) [ Time Frame: baseline and week 4 ]
    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.

  5. Trunk Impairment Scale [ Time Frame: baseline and week 4 ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745481


Contacts
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Contact: Yong-il Shin, PhD 082+01065350310 rm01shin@gmail.com

Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Study Director: Yong-il Shin, PhD Pusan National University Yangsan Hospital
More Information
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Publications:

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Responsible Party: Yong-il Shin, Head of Rehabilitation Medicine, Principal Investigator, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT04745481    
Other Study ID Numbers: 03-2020-010
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yong-il Shin, Pusan National University Yangsan Hospital:
trunk stabilization training
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases