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Completed

NCT Number: NCT04745481

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trunk stabilization training device

Device

Conventional rehabilitation 30min daily, 20times 4weeks

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

Other names: Balance Pro(SBT-330)

Conventional rehabilitation

Device

Conventional rehabilitation 30min daily, 20times 4weeks

+Conventional rehabilitation 30min daily, 20times 4weeks

Other names: Ergometer, Stepper

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2021
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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