The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Upper extremity motor ability-Baseline
研究概览
简要总结
Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function without a cause other than vascular causes. As it is known, it is important for patients to regain functional skills in the upper extremities after stroke. Modified-Constraint Induced Movement Therapy (m-CIMT) is a versatile neurorehabilitation technique that aims to improve motor function in the hemiparetic upper extremity and increase its use in daily life activities. However, as in the Covid-19 pandemic, patients cannot always reach rehabilitation services. In such cases, telerehabilitation is a treatment option. There are a limited number of studies in which m-CIMT is applied according to the principle of telerehabilitation, which has become a necessity, especially due to the Covid-19 pandemic. Therefore, the aim of this study is to examine the effects of m-CIMT on upper extremity motor functions in stroke patients.
详细描述
This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Patients in both groups will be given lower-upper extremity exercises and gait training exercises selected according to the Bobath approach as a home program consisting of 10 exercises to be applied 5 days a week for 3 weeks. All patients will perform the same exercises. In addition, the exercise group will receive Modified-Constraint Induced Movement Therapy (m-CIMT) based telerehabilitation via video conferencing 5 days a week for 3 weeks. Patients in the m-CIMT group will be asked to restrict the movements of their less affected hands by using mitt for 5 hours a day/ 5 days a week for 3 weeks while the patients are awake. Evaluations for both groups will be made by a physiotherapist blinded to the study twice, at the beginning and 3 weeks later. As outcome measures functional performance, hand strength, activities of daily living and quality of life will be evaluated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •Being diagnosed with stroke for the first time by a doctor
- •Having been diagnosed with stroke at least 1 month ago
- •Mini-Mental Test Score more than or equal 24
- •In the upper extremities; Starting from the angle of full flexion, wrist extension of at least 20° or more, thumb extension or abduction of at least 10°, minimum extension of all other fingers at the metacarpophalangeal and interphalangeal joints
- •Having less than 2.5 points in the pre-treatment evaluation from both parts of MAG-28
- •Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
- •Absence of severe pain to affect the treatment
- •Absence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity ≤ 2 according to the Modified Ashworth Scale)
排除标准
- •Any orthopedic, vision, hearing or perception problems that may affect the research results
- •Having an additional neurological, cardiovascular, pulmonary or hormonal disorder that would prevent participation in the study.
结局指标
主要结局
Upper extremity motor ability-Baseline
时间窗: Assessment will be conducted before the intervention.
Wolf Motor Function Test
Upper extremity motor ability-Post intervention
时间窗: Assessment will be conducted immediately after the intervention.
Wolf Motor Function Test
Upper extremity motor function-Baseline
时间窗: Assessment will be conducted before the intervention.
The Fugl-Meyer Assessment of the Upper Extremity
Activities of daily living related to the upper extremity-Baseline
时间窗: Assessment will be conducted before the intervention.
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Activities of daily living related to the upper extremity-Post intervention
时间窗: Assessment will be conducted immediately after the intervention.
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Voluntary movement and mobility-Baseline
时间窗: Assessment will be conducted before the intervention.
Stroke Rehabilitation Assessment of Movement (STREAM)
Upper extremity motor function-Post intervention
时间窗: Assessment will be conducted immediately after the intervention.
The Fugl-Meyer Assessment of the Upper Extremity
Voluntary movement and mobility-Post intervention
时间窗: Assessment will be conducted immediately after the intervention.
Stroke Rehabilitation Assessment of Movement (STREAM)
次要结局
- Isometric hand strength-Baseline(Assessment will be conducted before the intervention.)
- Isometric pinch strength-Baseline(Assessment will be conducted before the intervention.)
- level of independence in activities of daily living-Post intervention(Assessment will be conducted immediately after the intervention.)
- level of independence in activities of daily living-Baseline(Assessment will be conducted before the intervention.)
- Isometric hand strength-Post intervention(Assessment will be conducted immediately after the intervention.)
- Isometric pinch strength-Post intervention(Assessment will be conducted immediately after the intervention.)
- manual dexterity performance-Baseline(Assessment will be conducted before the intervention.)
- manual dexterity performance-Post intervention(Assessment will be conducted immediately after the intervention.)
研究者
Fettah Saygılı
Principal Investigator
Gazi University