StrokeNCT07779928

An Innovative Proprioceptive Instrument for Upper Extremities

An observational study of Stroke and Shoulder Impingement Syndrome, run by National Cheng-Kung University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 20 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Stroke, Shoulder Impingement Syndrome, Diabetes (DM)
How many people: 280 participants
Where: No sites listed yet
Study dates: 1 Sep 2026to 31 Dec 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

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(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.
(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.
(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.
(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.

Who cannot join

(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) 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,

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(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) 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:
(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:
(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):
(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.

About this study

Official title: 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.

Conditions: Stroke, Shoulder Impingement Syndrome, Diabetes (DM), Healthy Young Adults, Healthy Adults, Healthy Older Adults
Keywords: Proprioception, Upper Extremities, Instrument, Psychometric Properties
Medical subject headings: Stroke, Shoulder Impingement Syndrome, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07779928
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
Measured: Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline
The MicroFET3 is used to quantify the muscle power of elbow
Measured: Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
Measured: Baseline
VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline
VICON is used to capture the position data of limbs in space.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202631 Dec 2027

First posted21 Aug 2026
Study start1 Sep 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 280 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07779928
Sponsor's protocol ID: A-ER-113-451
Status last verified: Feb 2026
First submitted: 17 Jul 2026
Last updated: 21 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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