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

May 29, 2024 updated by: Yong-il Shin, Pusan National University Yangsan Hospital

Effectiveness Evaluation of Trunk Stabilization Training Using Balance Pro(SBT-330) for Stroke Patients With Reduced Balance Ability

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Yangsan
      • Gyeongsang, Yangsan, Korea, Republic of, 50610
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Ergometer, Stepper

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline Berg Balance Scale at week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and week 4
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.
baseline and week 4
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.
baseline and week 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.
baseline and week 4
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.
baseline and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Investigators

  • Study Director: Yong-il Shin, PhD, Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-2020-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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