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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trunk stabilization training device | Experimental | Participants will receive conventional rehabilitation and use trunk stabilization training device 30min each daily, 20 times for 4weeks. |
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| Conventional rehabilitation | Active Comparator | Participants will receive conventional rehabilitation 60min daily, 20times for 4weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trunk stabilization training device | Device | Conventional rehabilitation 30min daily, 20times 4weeks +Trunk stabilization training device 30min daily, 20time 4weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline Berg Balance Scale at week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and week 4 |
| Functional Ambulation Category |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-il Shin, PhD | Pusan National University Yangsan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan national university Yangsan Hospital | Gyeongsang | Yangsan | 50610 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32282572 | Background | 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. | |
| 30852865 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional rehabilitation | Device | Conventional rehabilitation 30min daily, 20times 4weeks +Conventional rehabilitation 30min daily, 20times 4weeks |
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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 | 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) | 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 | 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 |
| 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |