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临床试验/NCT06261099
NCT06261099招募中不适用

The Effect of Telerehabilitation-Based Early Upper Extremity Training on Upper Extremity Function and Proprioception in Stroke Patients

Suleyman Demirel University4 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2024年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
4
主要终点
Mini Mental Test

研究概览

简要总结

Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic.

详细描述

After the sociodemographic data of the participants are recorded, Mini Mental Test (MMT) will be applied to evaluate the cognitive status. Upper extremity functions of patients eligible for the study will be evaluated with the Fugl-Meyer Upper Extremity Scale (FM-UE), proprioception evaluation will be evaluated with the Laser-pointer Assisted Angle Reproduction Test, activities of daily living will be evaluated with the Modified Barthel Index, and reaching performance will be evaluated with the Reaching Performance Scale. Characteristics of the patients participating in the study and all outcome measurements before and after treatment will be evaluated by a blinded physiotherapist. A researcher blinded to the exercise groups and evaluation results will perform the statistical analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Sealed envelopes will be prepared in advance for randomization and will be marked with numbers 1 and 2, indicating whether they are a study group or a control group. Randomization will be done by a third party unaware of the study content. Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded to which treatment group they will be included in.

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 30-65, with a history of stroke within the last month,
  • Mini Mental Score ≥ 24, 1-10 after discharge. on the day,
  • patients who can sit for at least 30 seconds, exhibit a hemiparetic condition, and are clinically stable

排除标准

  • Flaccid hemiplegia detected by anamnesis and physical examination,
  • Has spasticity in the upper extremity with a severity greater than 1+ according to the Modified Ashworth Scale,
  • patients with severe dementia and dysfunction of the upper extremity joints due to a previous musculoskeletal disease

研究组 & 干预措施

Control Group

No Intervention

Exercises including upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group, 5 sessions per week for 6 weeks. Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period. All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week.

kontrol+ working group

Experimental

Upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to the control group in 5 sessions per week for 6 weeks. The telerehabilitation program will be carried out using an application that provides remote video access called Zoom. Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period. All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week.

干预措施: control + working group (Other)

结局指标

主要结局

Mini Mental Test

时间窗: six weeks

It is used to evaluate the cognitive status of patients. It is a simple, short and valid test that is widely used in people with stroke. With this test, various cognitive functions of people such as orientation, recording memory, attention and calculation, recall and language are evaluated. The maximum score that can be obtained is 30. Getting a score of 24 or above indicates that the patient's cognitive functions are within normal limits.

Fugl Meyer Motor Function Scale

时间窗: six weeks

Motor performance is evaluated in stroke patients. Each item is given a score from 0 to 2, depending on performance: 2 points; complete detailing, 1 point; partial work of details, 0 points; It is given if details cannot be achieved. The maximum motor performance score for the upper extremity is 66 points.

Laser-pointer Assisted Angle Reproduction Test

时间窗: six weeks

It evaluates proprioceptive deviation in stroke patients. Shoulder flexion is measured three times at 45◦, 60◦ and 90◦, and upper extremity proprioception is evaluated by taking the average result of the three measurements.

Modified Barthel Index

时间窗: six weeks

Determines the functional adequacy, dependency level and rehabilitation services of stroke patients. Items on the scale are rated between 0 and 15 points in 5-point increments depending on the question. 0-20 points are considered fully dependent, 21-61 points are considered highly dependent, 62-90 points are considered moderately dependent, 91-99 points are considered mildly dependent, and 100 points are considered fully independent.

Reaching Performance Scale

时间窗: six weeks

It evaluates compensatory movements for upper extremity extension in stroke patients. Scores on items 1 to 5 are used to identify deficiencies in specific aspects of movement, with scores ranging from 0 to 18 being obtained depending on changing performance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Güler ERTUĞRUL

MSc student, physiotherapist

Suleyman Demirel University

研究点 (4)

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