- ICH GCP
- US-Register für klinische Studien
- Klinische 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)
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline
Zeitfenster: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline
Zeitfenster: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline
Zeitfenster: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Color Trails Test-Chinese Version (CTT-C) - Healthy Adult Group those who over 60 years-old - Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
|
The goniometer is used to measure the range of motion (ROM) of both sides of shoulders.
|
Baseline
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schulterverletzungen
- Erkrankungen des endokrinen Systems
- Erkrankungen des Bewegungsapparates
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Wunden und Verletzungen
- Gelenkerkrankungen
- Stoffwechselerkrankungen
- Störungen des Glukosestoffwechsels
- Ernährungs- und Stoffwechselerkrankungen
- Streicheln
- Diabetes Mellitus
- Schulter-Impingement-Syndrom
Andere Studien-ID-Nummern
- A-ER-113-451
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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