- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07779928
An Innovative Proprioceptive Instrument for Upper Extremities
Development, Validation, and Clinical Application of an Innovative Proprioceptive Instrument for Upper Extremities: PropArm-PosiMoF (PropArm)
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Healthy Young Adults
20-29 years-old
|
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Healthy Adults
30-59 years-old
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Healthy Older Adults
60-89 years-old
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Stroke
20-89 year-old
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Shoulder Impingement Syndrome
20-89 year-old
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Diabetes (DM)
20-89 years-old
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
Časové okno: 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
|
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PropArm-PosiMoF (PropArm) - Healthy Adult Group - Baseline
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline
Časové okno: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline
Časové okno: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline
Časové okno: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline
Časové okno: 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
Časové okno: 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
|
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Manual Tactile Test-Barognosis (MTT-B) - Healthy Adult Group - Baseline
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Color Trails Test-Chinese Version (CTT-C) - Healthy Adult Group those who over 60 years-old - Baseline
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
The FMA-UE is used to measure the motor function of affected hand in stroke patients.
|
Baseline
|
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Goniometer Shoulder Range of Motion - Shoulder Impingement Syndrome Group - Baseline
Časové okno: Baseline
|
The goniometer is used to measure the range of motion (ROM) of both sides of shoulders.
|
Baseline
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Zranění ramen
- Onemocnění endokrinního systému
- Nemoci pohybového aparátu
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Rány a zranění
- Onemocnění kloubů
- Metabolické choroby
- Poruchy metabolismu glukózy
- Nutriční a metabolické nemoci
- Mrtvice
- Diabetes Mellitus
- Syndrom nárazového ramene
Další identifikační čísla studie
- A-ER-113-451
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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