An Innovative Proprioceptive Instrument for Upper Extremities

August 18, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

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.

Description

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:
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, within 2 weeks after Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline, within 2 weeks after Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Healthy Adult Group - Baseline Time Frame: Baseline	The MicroFET3 is used to quantify the muscle power of elbow.	Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline Time Frame: Baseline	The MicroFET3 is used to quantify the muscle power of elbow.	Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline Time Frame: Baseline	The MicroFET3 is used to quantify the muscle power of elbow	Baseline
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline Time Frame: Baseline	The MicroFET3 is used to quantify the muscle power of elbow.	Baseline
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.	Baseline
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.	Baseline, within 2 weeks after Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

August 18, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)