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

August 27, 2024 updated by: Universitas Padjadjaran

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Drop out criteria:

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 Withdrawn by themselves

Confounding factor:

  1. Stroke location
  2. Stroke size
  3. Spasticity
  4. Rehabilitation program
  5. Compliance rehabilitation
  6. 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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All stroke patients who meet the inclusion and exclusion criteria during the duration of the study.

Description

Inclusion Criteria:

  1. 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
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset
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)
3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 24, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKFR-202408.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sex Women Men Age Length of stay Stroke diagnosis Ischemic stroke Haemorrhagic stroke Stroke side Right hemisphere Left hemisphere Dominant Hand Right Left Stroke severity Minor stroke Moderate stroke Moderate to severe stroke Severe stroke Stroke risk factor Hypertension Diabetes Mellitus Heart disease Dyslipidemia Smoking Recurrent stroke Yes No

IPD Sharing Time Frame

February 2025 - July 2025

IPD Sharing Access Criteria

With access article/journal

With participants characteristics:

Sex Women Men Age Length of stay Stroke diagnosis Ischemic stroke Haemorrhagic stroke Stroke side Right hemisphere Left hemisphere Dominant Hand Right Left Stroke severity Minor stroke Moderate stroke Moderate to severe stroke Severe stroke Stroke risk factor Hypertension Diabetes Mellitus Heart disease Dyslipidemia Smoking Recurrent stroke Yes No

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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