The Effects of Body Weight Supported Treadmill Training On Static And Dynamic Balance In Stroke Patients: A Randomized-Single Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
Stroke is one of the most common causes of acquired adult disability. The majority of stroke survivors have mobility difficulties such as poor standing, decreased walking speed, balance disturbances, and increased risk for falls. Improving mobility, functional walking and balance are the main goals of stroke rehabilitation. Robotic technologies are becoming more promising intervention for the locomotor training in stroke rehabilitation. Static or dynamic balance deficits act crucial role on gait performance among stroke survivors. Therefore it is important to determine the effects of BWSTT in improving balance in persons with stroke. Although it has been demonstrated that BWSTT improved balance and gait performance in stroke patients, it is not clear whether the improvements are greater compared with those associated with other gait rehabilitation methods. To the investigators knowledge, there are also limited studies in the literature concerning the effects of BWSTT on falling risk in stroke patients. The strong evidence is needed about the effectiveness of BWSTT including comprehensive determinants of balance with combined and isolated intervention groups.This study aims to compare the effects of BWSTT with combined and isolated intervention on balance, gait and fall risk in patients with subacute and chronic stroke. The investigators hypotheses are that after stroke:
- the combination of BWSTT with conventional training may lead to more improved balance parameters;
- when applied as an isolated intervention, BWSTT or conventional training may lead to similar results.
详细描述
Participants:
All participants with stroke were recruited from a government rehabilitation hospital between November 2014 and November 2015. All treatments were performed in the same hospital.
Sample Size:
"Power and Sample Size Program" was used to calculate sample size. It was determined by considering a previous study which calculated minimal detectable change of Berg Balance Scale (BBS) for stroke patients(20). According to this study to the response within each subject group was normally distributed with standard deviation 7.87 and minimal detectable change was found 10% for BBS. It was calculated that 15 participants were needed in each group with probability (power) 0.8 and 0.016 alpha level computed by Bonferroni adjustment.
Procedure:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke onset at least 3 months before the study
- •being 18-75 years old
- •to be able to walk 10 meter independently or under supervision
- •to be able to walk independently with or without ankle-foot-orthosis
- •to be able to understand all instructions during treatment sessions
排除标准
- •previously having stroke
- •having other health conditions which prevent walking
- •having contracture or range of motion limitation in lower extremity which affect walking
- •having uncontrolled hypertension
- •severe cognitive impairment
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: 6 weeks
This 14-item objective measure was used to assess postural control and balance of the participants. Item-level scores of BBS range from 0-4; summed score of the items were used in this study. Higher score indicates better mobility performance.
Timed Up and Go Test (TUG)
时间窗: 6 weeks
TUG is a reliable and simple test to assess balance and functional mobility of stroke patients. The patient sited in chair and with command of physiotherapist raised from the chair, walked 3 meters, walked back to the chair and sited down again. The time of process was recorded by the physiotherapist in seconds. It was allowed to use walking aid during the test. Lower duration indicates better mobility performance.
Single Leg Stance Test (SLST)
时间窗: 6 weeks
SLST was performed with eyes open while resting the arms on the hips. The participant stand on one leg with this position and timed in seconds from time one foot is flexed to time when s/he touched the ground, jumped or touched anything to support was calculated by the physiotherapist three times. After three trials the average of the three trials was recorded. Shortening the time to stand on one leg was a marker for decreased balance function.
The Falls Efficacy Scale-International (FES-I)
时间窗: 6 weeks
FES-I was used to assessed the anxiety level of participants about falling while performing activities indoor or outdoor. It has 16 items scored on a 4-point Likert scale. We used Turkish version of FES-I in our study. Higher score indicates better mobility performance.
次要结局
- The Comfortable and the Fast Gait Speed tests (CGS and FGS)(6 weeks)
- The Stair Climbing ascend and descend tests (SCas and SCde)(6 weeks)
- Rivermead Mobility Index (RMI)(6 weeks)
研究者
RUSTEM MUSTAFAOGLU
MSc, PT
Istanbul University