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- Klinische proef NCT07779928
An Innovative Proprioceptive Instrument for Upper Extremities
Development, Validation, and Clinical Application of an Innovative Proprioceptive Instrument for Upper Extremities: PropArm-PosiMoF (PropArm)
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Healthy Young Adults:
Inclusion Criteria:
- (1) Age between 20 and 29 years,
- (2) Right-hand dominance, and
- (3) Ability to understand three consecutive verbal instructions.
Exclusion Criteria:
- (1) Currently a student or faculty member of the Department of Occupational Therapy at National Cheng Kung University, or a staff member of the Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital,
- (2) History of surgery on the right upper limb,
- (3) Presence of neuromusculoskeletal disorders that may affect sensory or motor function of the right upper limb, such as stroke or shoulder impingement syndrome, and
- (4) Uncorrected hearing problems, such as hearing loss.
Healthy Adults:
Inclusion Criteria:
- (1) Age between 30 to 39, 40 to 49, or 50 to 59 years,
- (2) Right-hand dominance, and
- (3) Ability to understand three consecutive verbal instructions.
Exclusion Criteria:
- (1) Currently a student or faculty member of the Department of Occupational Therapy at National Cheng Kung University, or a staff member of the Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital,
- (2) History of surgery on the right upper limb,
- (3) Presence of neuromusculoskeletal disorders that may affect sensory or motor function of the right upper limb, such as stroke or shoulder impingement syndrome, and
- (4) Uncorrected hearing problems, such as hearing loss.
Healthy Older Adults:
Inclusion Criteria:
- (1) Age between 60 to 69, 70 to 79, or 80 to 89 years,
- (2) Right-hand dominance, and
- (3) Ability to understand three consecutive verbal instructions.
Exclusion Criteria:
- (1) Score below the 5th percentile on the Color Trails Test-Chinese Version (CTT-C),
- (2) Currently a student or faculty member of the Department of Occupational Therapy at National Cheng Kung University, or a staff member of the Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital,
- (3) History of surgery on the right upper limb,
- (4) Presence of neuromusculoskeletal disorders that may affect sensory or motor function of the right upper limb, such as stroke or shoulder impingement syndrome, and
- (5) Uncorrected hearing problems, such as hearing loss.
Stroke:
Inclusion Criteria:
- (1) Age between 20 and 89 years,
- (2) Right-hemispheric hemorrhagic or ischemic stroke with lesions involving proprioceptive pathways or the primary somatosensory cortex, potentially resulting in difficulties with body position, movement, or force perception, or with fine tactile perception (e.g., localization, two-point discrimination, object recognition),
- (3) Right-hand dominance, and
- (4) Ability to understand three consecutive verbal instructions.
Exclusion Criteria:
- (1) Score below the 5th percentile on the Color Trails Test-Chinese Version (CTT-C),
- (2) Upper limb still in acute pain stage,
- (3) Muscle tone severe enough to affect right upper limb movement (e.g., score ≥ 1+ on the Modified Ashworth Scale),
- (4) Uncorrected hearing problems, such as hearing loss.
Shoulder Impingement Syndrome:
Inclusion Criteria:
- (1) Age between 20 and 89 years,
- (2) Diagnosis of shoulder impingement syndrome in the right upper limb,
- (3) Right-hand dominance, and
- (4) Ability to understand three consecutive verbal instructions.
Exclusion Criteria:
- (1) Score below the 5th percentile on the Color Trails Test-Chinese Version (CTT-C),
- (2) Upper limb still in acute pain stage,
- (3) Uncorrected hearing problems, such as hearing loss.
- Diabetes (DM):
Inclusion Criteria:
- (1) Age between 20 and 89 years,
(2) Diagnosis of diabetes mellitus by a specialist physician, based on one of the following:
- Fasting plasma glucose (FPG) ≥ 126 mg/dL or 7.0 mmol/L;
- Hemoglobin A1C (HbA1c) ≥ 6.5%;
- Plasma glucose ≥ 200 mg/dL or 11.1 mmol/L at 2 hours during an oral glucose tolerance test (OGTT);
- Presence of hyperglycemia symptoms (polyphagia, polyuria, polydipsia, and unexplained weight loss) with a random plasma glucose ≥ 200 mg/dL.
Diagnosis of diabetes is confirmed if any two of items (a-c) are met, or if any one of them remains positive on repeat testing; fulfillment of item (d) alone is also sufficient for diagnosis.
- (3) Right-hand dominance, and
- (4) Ability to understand three consecutive verbal instructions.
Exclusion Criteria:
- (1) Score below the 5th percentile on the Color Trails Test-Chinese Version (CTT-C),
- (2) History of surgery on the right upper limb,
- (3) Presence of other neuromusculoskeletal disorders that may affect sensory or motor function of the right upper limb, and
- (4) Current skin infection, and
- (5) Uncorrected hearing problems, such as hearing loss.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Healthy Young Adults
20-29 years-old
|
|
Healthy Adults
30-59 years-old
|
|
Healthy Older Adults
60-89 years-old
|
|
Stroke
20-89 year-old
|
|
Shoulder Impingement Syndrome
20-89 year-old
|
|
Diabetes (DM)
20-89 years-old
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
Tijdsspanne: Baseline, within 2 weeks after Baseline
|
The instrument is designed to measure proprioception by recording position and force data.
In the first stage, PropArm was conducted twice to examine the test-retest reliability of healthy young adults.
In other stages, PropArm were collected once.
|
Baseline, within 2 weeks after Baseline
|
|
PropArm-PosiMoF (PropArm) - Healthy Adult Group - Baseline
Tijdsspanne: Baseline
|
The instrument is designed to measure proprioception by recording position and force data.
In the first stage, PropArm was conducted twice to examine the test-retest reliability of healthy young adults.
In other stages, PropArm were collected once.
|
Baseline
|
|
PropArm-PosiMoF (PropArm) - Stroke Group - Baseline
Tijdsspanne: Baseline
|
The instrument is designed to measure proprioception by recording position and force data.
In the first stage, PropArm was conducted twice to examine the test-retest reliability of healthy young adults.
In other stages, PropArm were collected once.
|
Baseline
|
|
PropArm-PosiMoF (PropArm) - Shoulder Impingement Syndrome Group - Baseline
Tijdsspanne: Baseline
|
The instrument is designed to measure proprioception by recording position and force data.
In the first stage, PropArm was conducted twice to examine the test-retest reliability of healthy young adults.
In other stages, PropArm were collected once.
|
Baseline
|
|
PropArm-PosiMoF (PropArm) - Diabetes Mellitus Group - Baseline
Tijdsspanne: Baseline
|
The instrument is designed to measure proprioception by recording position and force data.
In the first stage, PropArm was conducted twice to examine the test-retest reliability of healthy young adults.
In other stages, PropArm were collected once.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
Tijdsspanne: Baseline, within 2 weeks after Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline, within 2 weeks after Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Healthy Adult Group - Baseline
Tijdsspanne: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline
Tijdsspanne: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline
Tijdsspanne: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline
Tijdsspanne: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline
Tijdsspanne: Baseline
|
VICON is used to capture the position data of limbs in space.
|
Baseline
|
|
Manual Tactile Test-Barognosis (MTT-B) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
Tijdsspanne: Baseline, within 2 weeks after Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline, within 2 weeks after Baseline
|
|
Manual Tactile Test-Barognosis (MTT-B) - Healthy Adult Group - Baseline
Tijdsspanne: Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline
|
|
Manual Tactile Test-Barognosis (MTT-B) - Stroke Group - Baseline
Tijdsspanne: Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline
|
|
Manual Tactile Test-Barognosis (MTT-B) - Shoulder Impingement Syndrome Group - Baseline
Tijdsspanne: Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline
|
|
Manual Tactile Test-Barognosis (MTT-B) - Diabetes Mellitus Group - Baseline
Tijdsspanne: Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Color Trails Test-Chinese Version (CTT-C) - Healthy Adult Group those who over 60 years-old - Baseline
Tijdsspanne: Baseline
|
The CTT-C is a screening test used to exclude potential mild cognitive impairment patients.
|
Baseline
|
|
Color Trails Test-Chinese Version (CTT-C) - Stroke Group those who over 60 years-old - Baseline
Tijdsspanne: Baseline
|
The CTT-C is a screening test used to exclude potential mild cognitive impairment patients.
|
Baseline
|
|
Color Trails Test-Chinese Version (CTT-C) - Shoulder Impingement Syndrome Group those who over 60 years-old - Baseline
Tijdsspanne: Baseline
|
The CTT-C is a screening test used to exclude potential mild cognitive impairment patients.
|
Baseline
|
|
Color Trails Test-Chinese Version (CTT-C) -Diabetes Mellitus Group those who over 60 years-old - Baseline
Tijdsspanne: Baseline
|
The CTT-C is a screening test used to exclude potential mild cognitive impairment patients.
|
Baseline
|
|
Fugl-Meyer Assessment-Upper Extremity (FMA-UE) - Stroke Group - Baseline
Tijdsspanne: Baseline
|
The FMA-UE is used to measure the motor function of affected hand in stroke patients.
|
Baseline
|
|
Goniometer Shoulder Range of Motion - Shoulder Impingement Syndrome Group - Baseline
Tijdsspanne: Baseline
|
The goniometer is used to measure the range of motion (ROM) of both sides of shoulders.
|
Baseline
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Schouder blessures
- Endocriene systeemziekten
- Musculoskeletale aandoeningen
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Vaatziekten
- Hart-en vaatziekten
- Wonden en verwondingen
- Gewrichtsziekten
- Metabole ziekten
- Glucosemetabolismestoornissen
- Voedings- en stofwisselingsziekten
- Hartinfarct
- Suikerziekte
- Schouder Impingement Syndroom
Andere studie-ID-nummers
- A-ER-113-451
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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