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Not yet recruitingNCT07779928Updated Aug 21, 2026

An Innovative Proprioceptive Instrument for Upper Extremities

An observational study in Stroke, Shoulder Impingement Syndrome and Diabetes (DM), sponsored by National Cheng-Kung University Hospital. Not yet recruiting. Open to participants aged 20 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by National Cheng-Kung University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
280
Ages
20 Years to 89 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Stroke
  • Shoulder Impingement Syndrome
  • Diabetes (DM)
  • Healthy Young Adults
  • Healthy Adults
  • Healthy Older Adults

Keywords

  • Proprioception
  • Upper Extremities
  • Instrument
  • Psychometric Properties
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 280 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 277 studies on the registry; 70 are open to participants now.

Browse National Cheng-Kung University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

  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. (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
280 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - 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.

    Time frame: Baseline, within 2 weeks after Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

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

    Time frame: Baseline, within 2 weeks after Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

    The MicroFET3 is used to quantify the muscle power of elbow

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline, within 2 weeks after Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

Other outcomes

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07779928
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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