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StrokeNCT04745481

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

A study testing Trunk stabilization training device and Conventional rehabilitation in people with Stroke, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Stroke
What is being tested?
Trunk stabilization training device and Conventional rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSouth Korea
Study dates
15 Mar 2021to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Pusan national university Yangsan Hospital

    Gyeongsang, Yangsan, 50610

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Conditions
Stroke
Being tested
Trunk stabilization training device, Conventional rehabilitation
Keywords
trunk stabilization training
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trunk stabilization training deviceDevice

    Also called Balance Pro(SBT-330)

    Conventional rehabilitation 30min daily, 20times 4weeks

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

  • Conventional rehabilitationDevice

    Also called Ergometer, Stepper

    Conventional rehabilitation 30min daily, 20times 4weeks

    +Conventional rehabilitation 30min daily, 20times 4weeks

Study groups in NCT04745481
Study groupRoleWhat they receive
Trunk stabilization training deviceExperimentalParticipants will receive conventional rehabilitation and use trunk stabilization training device 30min each daily, 20 times for 4weeks.
Receives: Device: Trunk stabilization training device
Conventional rehabilitationActive comparatorParticipants will receive conventional rehabilitation 60min daily, 20times for 4weeks.
Receives: Device: Conventional rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline Berg Balance Scale at week 4

Secondary outcomes (5)

  1. 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.

    Measured: baseline and week 4

  2. 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.

    Measured: baseline and week 4

  3. 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.

    Measured: baseline and week 4

  4. 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.

    Measured: baseline and week 4

  5. 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.

    Measured: baseline and week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2021
  2. Study start15 Mar 2021
  3. Primary completion30 May 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04745481
Sponsor's protocol ID
03-2020-010
Status last verified
May 2024
First submitted
31 Jan 2021
Last updated
31 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32282572

  • 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.

    PubMed 30852865

Questions about this trial

What is this clinical trial studying?

A study testing Trunk stabilization training device and Conventional rehabilitation in people with Stroke, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Berg Balance Scale (time frame: Change from baseline Berg Balance Scale at week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04745481, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.

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