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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745481
• Other study ID #: 03-2020-010
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2024
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Trunk stabilization training device
Conventional rehabilitation 30min daily, 20times 4weeks +Trunk stabilization training device 30min daily, 20time 4weeks
• Conventional rehabilitation
Conventional rehabilitation 30min daily, 20times 4weeks +Conventional rehabilitation 30min daily, 20times 4weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan national university Yangsan Hospital	Gyeongsang	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	baseline and week 4
Secondary	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
Secondary	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
Secondary	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