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An Innovative Proprioceptive Instrument for Upper Extremities

2026. augusztus 18. frissítette: National Cheng-Kung University Hospital

Development, Validation, and Clinical Application of an Innovative Proprioceptive Instrument for Upper Extremities: PropArm-PosiMoF (PropArm)

This study aimed to develop and validate an innovative proprioceptive assessment instrument for the upper extremities, the PropArm-PosiMoF (PropArm). This observational study was conducted in three stages. The first stage focused on the development and validation of PropArm, including test-retest reliability, concurrent validity, and convergent validity. The second stage established age norms and cut-off points in healthy adults. In the final stage, PropArm was applied to patients with proprioceptive impairments (stroke, shoulder impingement syndrome, and diabetes mellitus patients) to examine its diagnostic accuracy and clinical applicability.

A tanulmány áttekintése

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

280

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Igen

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

The study population includes healthy young adults (20-29 yr), healthy adults (30-39, 40-49, and 50-59 yr), healthy older adults (60-69, 70-79, and 80-89 yr) across different age groups, and patients with stroke, shoulder impingement syndrome, or diabetes mellitus. Participants are right-hand dominant and able to follow verbal instructions without cognitive impairments.

Leírás

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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:

    1. Fasting plasma glucose (FPG) ≥ 126 mg/dL or 7.0 mmol/L;
    2. Hemoglobin A1C (HbA1c) ≥ 6.5%;
    3. Plasma glucose ≥ 200 mg/dL or 11.1 mmol/L at 2 hours during an oral glucose tolerance test (OGTT);
    4. 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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
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

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline
Időkeret: Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline
Időkeret: Baseline
The MicroFET3 is used to quantify the muscle power of elbow
Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline
Időkeret: Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
Baseline
VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
Baseline

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Color Trails Test-Chinese Version (CTT-C) - Healthy Adult Group those who over 60 years-old - Baseline
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline
The goniometer is used to measure the range of motion (ROM) of both sides of shoulders.
Baseline

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 1.

Elsődleges befejezés (Becsült)

2027. december 31.

A tanulmány befejezése (Becsült)

2027. december 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 17.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 18.

Első közzététel (Tényleges)

2026. augusztus 21.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 21.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 18.

Utolsó ellenőrzés

2026. február 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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