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NCT Number: NCT07779928

An Innovative Proprioceptive Instrument for Upper Extremities

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline

    Time frame: 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.

  2. PropArm-PosiMoF (PropArm) - Healthy Adult Group - Baseline

    Time frame: 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.

  3. PropArm-PosiMoF (PropArm) - Stroke Group - Baseline

    Time frame: 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.

  4. PropArm-PosiMoF (PropArm) - Shoulder Impingement Syndrome Group - Baseline

    Time frame: 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.

  5. PropArm-PosiMoF (PropArm) - Diabetes Mellitus Group - Baseline

    Time frame: 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.

  6. MicroFET3 Hand-held Dynamometer (MicroFET3) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline

    Time frame: Baseline, within 2 weeks after Baseline

    The MicroFET3 is used to quantify the muscle power of elbow.

  7. MicroFET3 Hand-held Dynamometer (MicroFET3) - Healthy Adult Group - Baseline

    Time frame: Baseline

    The MicroFET3 is used to quantify the muscle power of elbow.

  8. MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline

    Time frame: Baseline

    The MicroFET3 is used to quantify the muscle power of elbow.

  9. MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline

    Time frame: Baseline

    The MicroFET3 is used to quantify the muscle power of elbow

  10. MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline

    Time frame: Baseline

    The MicroFET3 is used to quantify the muscle power of elbow.

  11. VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline

    Time frame: Baseline

    VICON is used to capture the position data of limbs in space.

  12. Manual Tactile Test-Barognosis (MTT-B) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline

    Time frame: Baseline, within 2 weeks after Baseline

    The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.

  13. Manual Tactile Test-Barognosis (MTT-B) - Healthy Adult Group - Baseline

    Time frame: Baseline

    The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.

  14. Manual Tactile Test-Barognosis (MTT-B) - Stroke Group - Baseline

    Time frame: Baseline

    The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.

  15. Manual Tactile Test-Barognosis (MTT-B) - Shoulder Impingement Syndrome Group - Baseline

    Time frame: Baseline

    The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.

  16. Manual Tactile Test-Barognosis (MTT-B) - Diabetes Mellitus Group - Baseline

    Time frame: Baseline

    The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.

Other outcomes

  1. Color Trails Test-Chinese Version (CTT-C) - Healthy Adult Group those who over 60 years-old - Baseline

    Time frame: Baseline

    The CTT-C is a screening test used to exclude potential mild cognitive impairment patients.

  2. Color Trails Test-Chinese Version (CTT-C) - Stroke Group those who over 60 years-old - Baseline

    Time frame: Baseline

    The CTT-C is a screening test used to exclude potential mild cognitive impairment patients.

  3. Color Trails Test-Chinese Version (CTT-C) - Shoulder Impingement Syndrome Group those who over 60 years-old - Baseline

    Time frame: Baseline

    The CTT-C is a screening test used to exclude potential mild cognitive impairment patients.

  4. Color Trails Test-Chinese Version (CTT-C) -Diabetes Mellitus Group those who over 60 years-old - Baseline

    Time frame: Baseline

    The CTT-C is a screening test used to exclude potential mild cognitive impairment patients.

  5. Fugl-Meyer Assessment-Upper Extremity (FMA-UE) - Stroke Group - Baseline

    Time frame: Baseline

    The FMA-UE is used to measure the motor function of affected hand in stroke patients.

  6. Goniometer Shoulder Range of Motion - Shoulder Impingement Syndrome Group - Baseline

    Time frame: Baseline

    The goniometer is used to measure the range of motion (ROM) of both sides of shoulders.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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