Effectiveness Evaluation of Trunk Stabilization Training Using Balance Pro(SBT-330) for Stroke Patients With Reduced Balance Ability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change of Berg Balance Scale
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Conventional rehabilitation
Participants will receive conventional rehabilitation 60min daily, 20times for 4weeks.
干预措施: Conventional rehabilitation (Device)
Trunk stabilization training device
Participants will receive conventional rehabilitation and use trunk stabilization training device 30min each daily, 20 times for 4weeks.
干预措施: Trunk stabilization training device (Device)
结局指标
主要结局
Change of Berg Balance Scale
时间窗: 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.
次要结局
- Fugl-Meyer Assessment(L/E)(baseline and week 4)
- Functional Ambulation Category(baseline and week 4)
- Trunk Impairment Scale(baseline and week 4)
- Timed Up and Go test(baseline and week 4)
- Korean version of Modified Barthel Index(baseline and week 4)
研究者
Yong-il Shin
Head of Rehabilitation Medicine, Principal Investigator
Pusan National University Yangsan Hospital