Development, Validation, and Clinical Application of an Innovative Proprioceptive Instrument for Upper Extremities: PropArm-PosiMoF (PropArm)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 主要终点
- PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •(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.
- •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;
- 另有 12 项未显示
研究组 & 干预措施
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
结局指标
主要结局
PropArm-PosiMoF (PropArm) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
时间窗: 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.
PropArm-PosiMoF (PropArm) - Healthy Adult Group - Baseline
时间窗: 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.
PropArm-PosiMoF (PropArm) - Stroke Group - Baseline
时间窗: 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.
PropArm-PosiMoF (PropArm) - Shoulder Impingement Syndrome Group - Baseline
时间窗: 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.
PropArm-PosiMoF (PropArm) - Diabetes Mellitus Group - Baseline
时间窗: 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.
MicroFET3 Hand-held Dynamometer (MicroFET3) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
时间窗: Baseline, within 2 weeks after Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
MicroFET3 Hand-held Dynamometer (MicroFET3) - Healthy Adult Group - Baseline
时间窗: Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
MicroFET3 Hand-held Dynamometer (MicroFET3) - Stroke Group - Baseline
时间窗: Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
MicroFET3 Hand-held Dynamometer (MicroFET3) - Shoulder Impingement Syndrome Group - Baseline
时间窗: Baseline
The MicroFET3 is used to quantify the muscle power of elbow
MicroFET3 Hand-held Dynamometer (MicroFET3) - Diabetes Mellitus Group - Baseline
时间窗: Baseline
The MicroFET3 is used to quantify the muscle power of elbow.
VICON Motion Capture System (VICON) - Healthy Young Adult Group - Baseline
时间窗: Baseline
VICON is used to capture the position data of limbs in space.
Manual Tactile Test-Barognosis (MTT-B) - Healthy Young Adult Group - Baseline, within 2 weeks after Baseline
时间窗: Baseline, within 2 weeks after Baseline
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
Manual Tactile Test-Barognosis (MTT-B) - Healthy Adult Group - Baseline
时间窗: Baseline
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
Manual Tactile Test-Barognosis (MTT-B) - Stroke Group - Baseline
时间窗: Baseline
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
Manual Tactile Test-Barognosis (MTT-B) - Shoulder Impingement Syndrome Group - Baseline
时间窗: Baseline
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
Manual Tactile Test-Barognosis (MTT-B) - Diabetes Mellitus Group - Baseline
时间窗: Baseline
The MTT-B is used to assess the ability to discriminate objects without vision (barognosis sense) of hand.
次要结局
未报告次要终点