- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07779928
An Innovative Proprioceptive Instrument for Upper Extremities
Development, Validation, and Clinical Application of an Innovative Proprioceptive Instrument for Upper Extremities: PropArm-PosiMoF (PropArm)
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline
Délai: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline
Délai: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline
Délai: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Color Trails Test-Chinese Version (CTT-C) - Healthy Adult Group those who over 60 years-old - Baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
|
The goniometer is used to measure the range of motion (ROM) of both sides of shoulders.
|
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Blessures à l'épaule
- Maladies du système endocrinien
- Maladies musculo-squelettiques
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Blessures et Blessures
- Maladies articulaires
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Maladies nutritionnelles et métaboliques
- Accident vasculaire cérébral
- Diabète sucré
- Syndrome de conflit d'épaule
Autres numéros d'identification d'étude
- A-ER-113-451
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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