Clinical trial NCT04745481: Effects of Trunk Stabilization Training Device on Balance Ability for Stroke Patients
Official title: Effectiveness Evaluation of Trunk Stabilization Training Using Balance Pro(SBT-330) for Stroke Patients With Reduced Balance Ability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: trunk stabilization training
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Berg Balance Scale
timeFrame: Change from baseline Berg Balance Scale at week 4
Secondary outcomes:
measure: Timed Up and Go test
timeFrame: baseline and week 4
measure: Functional Ambulation Category
timeFrame: baseline and week 4
measure: Korean version of Modified Barthel Index
timeFrame: baseline and week 4
measure: Fugl-Meyer Assessment(L/E)
timeFrame: baseline and week 4
measure: Trunk Impairment Scale
timeFrame: baseline and week 4
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong-il Shin, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.