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临床试验/NCT06574737
NCT06574737招募中不适用

Use of Surface Electromyography as a Tools to Predict Upper Extremity Recovery Function After Stroke

Universitas Padjadjaran1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Electrical activity deltoid, biceps, triceps, wrist flexor, wrist extensor muscle

研究概览

简要总结

Hypothesis :

Based on the framework and premises above, the hypothesis is formulated as follows: H0 : surface electromyography parameters cannot predicts upper extremity motor function recovery in stroke patients H1: surface electromyography parameters can predicts upper extremity motor function recovery in stroke patients

详细描述

Study design and setting This study is an analytic quantitative observational study, to analyse the quantification of Manual Muscle Test score, Fugl Mayer Assessment-Upper Extremity score and electrical signals of the anterior deltoid, biceps, triceps, wrist flexors and wrist extensors muscles based on contractions, length of contraction and amplitude parameters in patients with acute phase stroke. This study performed at HasanSadikin Hospital between February 2024 - July 2024. Study participants Potential participants will be recruited by the main researcher

Inclusion criteria:

  1. Patients who are hospitalized with upper extremity weakness due to stroke on the same side which confirmed with computed tomography scan or structural magnetic resonance imaging, in the acute phase
  2. Men and women aged more than 18 years old
  3. Willing to participate

Exclusion criteria:

  1. Cognitive impairment (MoCA-Ina score less than 26)
  2. Impaired consciousness (GCS score less than 15)
  3. Unstable medical conditions at time of hospitalization
  4. Patients with pacemaker
  5. Having other injury or dysfunction in the impaired side of upper extremity that caused restrictions on the range of joint movement and muscle weakness, such as fractures, periarthritis, or moderate-severe pain
  6. Diagnosis of other neurological disease or disorders in addition to stroke (e.g., traumatic brain injury, neuropathy or radiculopathy)
  7. Get treated in isolation room
  8. Hypersensitivity to gel electrodes

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • Patients who are hospitalized with upper extremity weakness due to stroke on the same side which confirmed with computed tomography (CT) scan or structural magnetic resonance imaging (MRI), in the acute phase
  • Men and women aged more than 18 years old
  • Willing to participate

排除标准

  • Cognitive impairment (MoCA-Ina score less than 26)
  • Impaired consciousness (GCS score less than 15)
  • Unstable medical conditions at time of hospitalization
  • Patients with pacemaker
  • Having other injury or dysfunction in the impaired side of upper extremity that caused restrictions on the range of joint movement and muscle weakness, such as fractures, periarthritis, or moderate-severe pain
  • Diagnosis of other neurological disease or disorders in addition to stroke (e.g., traumatic brain injury, neuropathy or radiculopathy)
  • Get treated in isolation room
  • Hypersensitivity to gel electrodes

结局指标

主要结局

Electrical activity deltoid, biceps, triceps, wrist flexor, wrist extensor muscle

时间窗: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset

* Contraction (number/minute). The number of contractions was reported for each participant as a count of the number of contractions divided per minute time (the more the better outcome) windows analyzed for that participant. * Length of contraction (millisecond) (the longer the better outcome) * Amplitude (mV) (the more the better outcome)

次要结局

  • Fugl Mayer Assessment-Upper Extremity score(3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset)
  • Manual Muscle Testing score(3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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