An observational study in Upper Extremity Paresis, Muscle Contracture Upper Arm and Stroke, sponsored by Universitas Padjadjaran. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Universitas Padjadjaran · Observational
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 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:
Exclusion criteria:
Drop out criteria:
Confounding 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.
468 studies on the registry are indexed under Paresis; 117 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 42 observational studies indexed under Paresis.
Browse Paresis studies →Universitas Padjadjaran is the lead sponsor of 93 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All stroke patients who meet the inclusion and exclusion criteria during the duration of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Time frame: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset
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)
Time frame: 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
≤25 : severe 26-45 : moderate 46-66 : mild (66 : maximum score for upper extremity score = normal, the more the better outcome)
Time frame: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan
Time frame: February 2025 - July 2025
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
Started May 2024 (actual). Primary completion is estimated for Apr 2025, 11 months after the start.
Of 22 observational studies under Paresis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 68. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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Universitas Padjadjaran