- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07779928
An Innovative Proprioceptive Instrument for Upper Extremities
Development, Validation, and Clinical Application of an Innovative Proprioceptive Instrument for Upper Extremities: PropArm-PosiMoF (PropArm)
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline
Tidsram: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline
Tidsram: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow
|
Baseline
|
|
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline
Tidsram: Baseline
|
The MicroFET3 is used to quantify the muscle power of elbow.
|
Baseline
|
|
VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
|
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
|
Baseline
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Color Trails Test-Chinese Version (CTT-C) - Healthy Adult Group those who over 60 years-old - Baseline
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
|
The goniometer is used to measure the range of motion (ROM) of both sides of shoulders.
|
Baseline
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Axelskador
- Sjukdomar i det endokrina systemet
- Muskuloskeletala sjukdomar
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Sår och skador
- Ledsjukdomar
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Närings- och metabola sjukdomar
- Stroke
- Diabetes mellitus
- Shoulder Impingement Syndrome
Andra studie-ID-nummer
- A-ER-113-451
Läkemedels- och apparatinformation, studiedokument
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