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NCT Number: NCT06574737

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

  • 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
  • Men and women aged more than 18 years old
  • Willing to participate

Exclusion criteria

  • 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

Drop out criteria:

  • Unable to do 2 or more follow up session
  • Withdrawn by themselves

Confounding factor:

  • Stroke location
  • Stroke size
  • Spasticity
  • Rehabilitation program
  • Compliance rehabilitation
  • Stroke risk factor

Sampling Technique The method of sampling based on consecutive samplings, that is, all stroke patients who meet the inclusion and exclusion criteria during the duration of the study.

Based on the formula above, the minimum sample size for this research is adequate, so the minimum sample size is 30 samples.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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)

Secondary outcomes

  1. Manual Muscle Testing score

    Time frame: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset

    5: Normal 4: Good 3: Fair 2: Poor

    1: Trace 0: Zero

    (5 : higher end of strength ability, 0 = low-end ability of strength ability) (the more, the better outcome)

  2. Fugl Mayer Assessment-Upper Extremity score

    Time frame: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset

    ≤25 : severe 26-45 : moderate 46-66 : mild

    (66 : maximum score for upper extremity score = normal, the more the better outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Berthy Al mungiza, Bachelor

CONTACT

[email protected]

+62 857-4752-0920

Vitriana Biben, Doctoral

CONTACT

[email protected]

022-7302-931

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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