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An Innovative Proprioceptive Instrument for Upper Extremities

18 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

280

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

  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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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

Co mierzy badanie?

Podstawowe miary wyniku

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Color Trails Test-Chinese Version (CTT-C) - Healthy Adult Group those who over 60 years-old - Baseline
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
The goniometer is used to measure the range of motion (ROM) of both sides of shoulders.
Baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

31 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

17 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

21 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 sierpnia 2026

Ostatnia weryfikacja

1 lutego 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • A-ER-113-451

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .