NCT07779928

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 21, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

July 17, 2026

Last Update Submit

August 18, 2026

Conditions

Keywords

ProprioceptionUpper ExtremitiesInstrumentPsychometric Properties

Outcome Measures

Primary Outcomes (16)

  • 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.

    Baseline, within 2 weeks after Baseline

  • 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.

    Baseline

  • 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.

    Baseline

  • 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.

    Baseline

  • 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.

    Baseline

  • 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.

    Baseline, within 2 weeks after Baseline

  • MicroFET3 Hand-held Dynamometer (MicroFET3) - Healthy Adult Group - Baseline

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

    Baseline

  • MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline

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

    Baseline

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

    The MicroFET3 is used to quantify the muscle power of elbow

    Baseline

  • MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline

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

    Baseline

  • VICON Motion Capture System (VICON) - Healthy Young Adult Group - 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

    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

    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

    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

    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

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

    Baseline

Other Outcomes (6)

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

    Baseline

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

    Baseline

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

    Baseline

  • +3 more other outcomes

Study Arms (6)

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

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • (1) Age between 20 and 29 years,
  • (2) Right-hand dominance, and
  • (3) Ability to understand three consecutive verbal instructions.

You may not qualify if:

  • (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:
  • (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.
  • (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:
  • (1) Age between 60 to 69, 70 to 79, or 80 to 89 years,
  • (2) Right-hand dominance, and
  • +38 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeShoulder Impingement SyndromeDiabetes Mellitus

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesJoint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

August 21, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 21, 2026

Record last verified: 2026-02