Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Timed Get Up and Go Test
研究概览
简要总结
In the literature, it has been observed that traditional balance training (TBT) and robot-assisted walking training (RAGT) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. However, it is seen that there is no clear protocol for RAGT in the chronic period. Combined RAGT and TBT approaches over ten weeks have been shown to be more effective than TBT alone for the acute and subacute period. However, there is no definite expression for chronic period effects. No study was found in the literature in which an objective measuring device was used for balance assessment of patients receiving TBT and RAGT. If changes are detected between the two treatment groups in balance education in stroke patients as a result of objective evaluation, our study will lead to the necessity of including these changes in the treatment. Considering the effect of balance on activities of daily living, we believe that objective evaluation of the changes in balance after TBT and RAGT in stroke patients and shaping the treatment according to the evaluation results will contribute to the literature.
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
- Double (Participant, 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
- •Being 18 years or older
- •Volunteering to participate in the study
- •Having been diagnosed with stroke (at least 3 months)
- •Age range 18 ≥ or 75 <
- •Being able to walk independently (Functional Ambulation Scale> 3)
- •Modified Ashworth Scale ≤ 2 spasticity value
排除标准
- •Being under the age of 18
- •Having severe visual and cognitive impairment
- •Having severe cardiovascular disease
- •Having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores)
- •Being involved in a robotic rehabilitation program before
结局指标
主要结局
Timed Get Up and Go Test
时间窗: 5 weeks
It is a measure for assessing balance and functional mobility. A chair and a stopwatch are required to administer the test. The shoes that are always used during the test are used and the test is continued with the assistive device if used. The person is asked to get up from a chair, walk 3 meters, turn around, walk back and sit, and the score is calculated by measuring how many seconds he or she completes the test. Completing the test in more than 12 seconds indicates that the risk of falling is high.
EncephaLog by Montfort® App
时间窗: 5 weeks
The phone, which is fixed to the sternum of the participant, evaluates the static and dynamic balance with the integration of accelerometer and gyroscope. Static balance is evaluated in a neutral stance with feet open, feet together, feet together and eyes closed, in tandem stance for 10 seconds for each test. Starts the dynamic balance assessment with a 5 second countdown followed by a short audible tone and vibration. Participants stand up without any assistance or arm support and walk at their natural speed towards a cone positioned on the ground 3 m from their chair, then turn around the cone and walk back and sit. It provides objective data by recording the walking time and the test is repeated twice.
Berg Balance Scale
时间窗: 5 weeks
It is used to evaluate postural control and to determine fall risk. It consists of 14 questions with parameters such as standing up from sitting, standing, transfers, taking a step, turning. A score of 0-4 is given for each question and the time the person performs the desired activity is recorded. At the end of the test, the total score received by the subject is calculated.
International Fall Efficiency Scale (FES-I)
时间窗: 5 weeks
It was developed to assess the fear of falling. The cut-off point is 24 to distinguish between people who have a fear of falling and those who do not. The participant is asked to rate his/her concern about the possibility of falling while performing activities of daily living. Fear of falling is determined by adding the scores between 1-4 obtained from each question after completing 16 questions.
次要结局
- Functional Ambulation Scale(5 weeks)
- Foot Posture Index(5 weeks)
- Modified Ashworth Scale(5 weeks)
- Fugl-Meyer Test- Lower Extremity(5 weeks)
研究者
Rüstem Mustafaoğlu
Associate Professor
Istanbul University - Cerrahpasa (IUC)