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Upper Extremity ParesisNCT06574737

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

An observational study of Upper Extremity Paresis and Muscle Contracture Upper Arm, run by Universitas Padjadjaran at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
30 participants
Where
1 siteIndonesia
Study dates
1 May 2024to 31 Jul 2025
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Vitriana Biben, Doctoral contact

022-7302-931

vitriana@unpad.ac.id

Berthy Al mungiza, Bachelor contact

+62 857-4752-0920

berthy.almungiza@gmail.com

Indonesia1 site, 1 recruiting

  • Berthy Al Mungiza

    Bandung, West Java, 40161

    Vitriana Biben, Doctoral, +62 815-6262-733, vitriana@unpad.ac.id

    Berthy Al Mungiza, Bachelor, +62 857-4752-0920, berthy.almungiza@gmail.com

    Recruiting

Other trials in Indonesia

About this study

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

Read the 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.

Keywords
Surface electromyography, Predictor Stroke, Upper Extremity Recovery
Medical subject headings
Paresis, Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    • 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)

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

Secondary outcomes (2)

  1. Manual Muscle Testing score

    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)

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

  2. Fugl Mayer Assessment-Upper Extremity score

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start1 May 2024
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
30 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574737
Sponsor's protocol ID
IKFR-202408.01
Status last verified
Aug 2024
First submitted
12 Aug 2024
Last updated
29 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Fan J, Li X, Yu X, Liu Z, Jiang Y, Fang Y, Zong M, Suo C, Man Q, Xiong L. Global Burden, Risk Factor Analysis, and Prediction Study of Ischemic Stroke, 1990-2030. Neurology. 2023 Jul 11;101(2):e137-e150. doi: 10.1212/WNL.0000000000207387. Epub 2023 May 17.

    PubMed 37197995

  • Venketasubramanian N, Yudiarto FL, Tugasworo D. Stroke Burden and Stroke Services in Indonesia. Cerebrovasc Dis Extra. 2022;12(1):53-57. doi: 10.1159/000524161. Epub 2022 Mar 21.

    PubMed 35313314

  • Shelton FN, Reding MJ. Effect of lesion location on upper limb motor recovery after stroke. Stroke. 2001 Jan;32(1):107-12. doi: 10.1161/01.str.32.1.107.

    PubMed 11136923

  • Lawrence ES, Coshall C, Dundas R, Stewart J, Rudd AG, Howard R, Wolfe CD. Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001 Jun;32(6):1279-84. doi: 10.1161/01.str.32.6.1279.

    PubMed 11387487

  • Feldner HA, Papazian C, Peters KM, Creutzfeldt CJ, Steele KM. Clinical Use of Surface Electromyography to Track Acute Upper Extremity Muscle Recovery after Stroke: A Descriptive Case Study of a Single Patient. Appl Syst Innov. 2021 Jun;4(2):32. doi: 10.3390/asi4020032. Epub 2021 May 10.

    PubMed 34778722

  • Steele KM, Papazian C, Feldner HA. Muscle Activity After Stroke: Perspectives on Deploying Surface Electromyography in Acute Care. Front Neurol. 2020 Sep 23;11:576757. doi: 10.3389/fneur.2020.576757. eCollection 2020.

    PubMed 33071953

  • Alt Murphy M, Al-Shallawi A, Sunnerhagen KS, Pandyan A. Early prediction of upper limb functioning after stroke using clinical bedside assessments: a prospective longitudinal study. Sci Rep. 2022 Dec 21;12(1):22053. doi: 10.1038/s41598-022-26585-1.

    PubMed 36543863

  • Papazian C, Baicoianu NA, Peters KM, Feldner HA, Steele KM. Electromyography Recordings Detect Muscle Activity Before Observable Contractions in Acute Stroke Care. Arch Rehabil Res Clin Transl. 2021 Jun 5;3(3):100136. doi: 10.1016/j.arrct.2021.100136. eCollection 2021 Sep.

    PubMed 34589686

  • Stinear CM, Smith MC, Byblow WD. Prediction Tools for Stroke Rehabilitation. Stroke. 2019 Nov;50(11):3314-3322. doi: 10.1161/STROKEAHA.119.025696. Epub 2019 Oct 15. No abstract available.

    PubMed 31610763

  • Manzur-Valdivia H, Alvarez-Ruf J. Surface Electromyography in Clinical Practice. A Perspective From a Developing Country. Front Neurol. 2020 Oct 15;11:578829. doi: 10.3389/fneur.2020.578829. eCollection 2020.

    PubMed 33178121

  • Ueda S, Aoki H, Yasuda Y, Nishiyama A, Hayashi Y, Honaga K, Tanuma A, Takakura T, Kurosu A, Hatori K, Hayashi A, Fujiwara T. The MMT of Elbow Flexion and the AFE Predict Impairment and Disability at 3 Weeks in Patients With Acute Stroke. Front Neurol. 2022 Mar 30;13:831800. doi: 10.3389/fneur.2022.831800. eCollection 2022.

    PubMed 35432154

  • Lv W, Liu K, Zhou P, Huang F, Lu Z. Surface EMG analysis of weakness distribution in upper limb muscles post-stroke. Front Neurol. 2023 Apr 25;14:1135564. doi: 10.3389/fneur.2023.1135564. eCollection 2023.

    PubMed 37181551

  • Raghavan P. Upper Limb Motor Impairment After Stroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):599-610. doi: 10.1016/j.pmr.2015.06.008. Epub 2015 Aug 25.

    PubMed 26522900

  • Li S. Stroke Recovery Is a Journey: Prediction and Potentials of Motor Recovery after a Stroke from a Practical Perspective. Life (Basel). 2023 Oct 15;13(10):2061. doi: 10.3390/life13102061.

    PubMed 37895442

  • Grefkes C, Fink GR. Recovery from stroke: current concepts and future perspectives. Neurol Res Pract. 2020 Jun 16;2:17. doi: 10.1186/s42466-020-00060-6. eCollection 2020.

    PubMed 33324923

Questions about this trial

What is this clinical trial studying?

An observational study of Upper Extremity Paresis and Muscle Contracture Upper Arm, run by Universitas Padjadjaran at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vitriana Biben, Doctoral (022-7302-931, vitriana@unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06574737, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.

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