Can Action Observation Therapy be an Alternative to Robotic Rehabilitation to Improve Upper Extremity Functions in Stroke Patients? A Protocol of Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Fugl Meyer Assessment for Upper Extremity
研究概览
简要总结
This protocol will investigate the effects of action observation therapy and robotic rehabilitation on upper extremity motor functions in subacute stroke patients. Firstly, for this purpose, conventional rehabilitation approaches will take 60 minutes before both treatment methods in stroke patients. The upper-limb conventional rehabilitation program will be applied to all patients according to their individual needs (60x3x8 minutes/day/week). This program will consist of purposeful clinical exercises with a physiotherapist.
After the conventional rehabilitation, one of the groups will receive action observation therapy, while the other will receive robotic rehabilitation. Both additional treatment methods will also be applied for 60 minutes. Treatment durations of both additional treatments are the same (60x3x8 minutes/day/week). Assessments will be made three times (Beginning, 4th week, 8th week).
详细描述
Randomization: The online randomization software (www.randomizer.org) will be used for the study. After randomization, patients will be divided into two groups (AOT group, Robotic group)
Blinding: Due to the nature of the study, patient-practitioner blinding is not possible. But an independent expert will perform the statistical analysis, and single-blind will be provided.
Estimating Sample Size: Gpower 3.1.9.7 software was used for sample size calculation. To calculate the effect size, the study of Lima and Christofoletti was taken as a reference, and the effect size was calculated as 1.29. The alpha error was accepted as 5% and the power of the study was 80%. Accordingly, considering that there may be missing data in the study, it was planned to include a minimum of 30 stroke patients.
Statistical Analysis
Statistical Package for the Social Sciences (SPSS v11.5) program will be used for analysis. Whether the data is normally distributed or not will be questioned by the Shapiro-Wilks test and histogram curves. When the data are normally distributed, Independent Sample T-test will be used for comparisons between groups, and Paired-Sample T-test will be used for comparisons within groups. When the data do not show normal distribution, Mann-Whitney U Test will be used for intergroup comparisons and Wilcoxon Signed Rank Test will be used for in-group comparisons.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18-80 aged
- •Stroke history in last six months
- •Mini-Mental Status Evaluation >24 points,
- •Having an Ability to sit independently,
- •Presence of at least half of the range of motion of all joints for the upper extremity,
- •Spasticity ≤ 2 according to the Modified Ashworth Scale,
- •The Fugl-Meyer Assessment for Upper Extremity score between 20-60,
- •Individuals without visual impairment,
- •Individuals with normal communication and cooperation skills.
排除标准
- •Having another neurological disease,
- •Having any orthopedic problems that may affect the upper extremity,
- •Taking neuropsychiatric treatment,
- •Individuals who had a botox history or tendon surgery,
- •Using neuroleptic drugs,
- •Having an ataxia,
- •Individuals who attended less than 80% of the total number of sessions.
结局指标
主要结局
Fugl Meyer Assessment for Upper Extremity
时间窗: End of the 8th week
This form is used to detect healing in the upper extremity.
Wolf Motor Function Test
时间窗: End of the 8th week
This test is used for the level of motor function.
次要结局
- Box and Block Test(End of the 8th week)
- Demographic Data Form(Baseline)
- Functional Independence questionnaire(End of the 8th week)
- The Stroke-Specific Quality of Life Scale (SS-QoL)(End of the 8th week)
研究者
Emre Şenocak
Research Assistant
Marmara University