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To address muscle weakness, sensory degradation, functional decline, and pain caused by geriatric syndromes in older adults and stroke survivors, this project proposes a series of studies aimed at improving neuromuscular performance, muscle strength, proprioceptive gain, functional outcomes, and pain relief through the use of a precise vibration system.
In the first phase, a vibration exercise system will be implemented to recruit frail older adults and older adults with stroke for clinical trials. The goal is to verify the benefits of vibration intervention on limb muscle strength, proprioception, and movement function.
In the third phase, quantitative pain assessments and related scales will be used to evaluate chronic pain thresholds and affected regions in older adults and stroke survivors, and to validate the effectiveness of vibration intervention in alleviating their pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older Adults (Conventional Rehabilitation) | Active Comparator | Older adults without stroke receive 60 minutes of conventional rehabilitation per session, including individualized strength, mobility, and balance training. Therapy duration is matched to the intervention group. Outcomes assessor is blinded. |
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| Older Adults (Vibration Therapy on Upper or Lower Limb) | Experimental | Older adults without stroke receive 20 minutes of precision vibration therapy (applied to the upper or lower limb according to primary deficit) followed by 40 minutes of conventional rehabilitation per session. The total session time equals 60 minutes. Outcomes assessor is blinded. |
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| Stroke Survivors (Conventional Rehabilitation) | Active Comparator | Stroke survivors (≥18 years) receive 60 minutes of conventional rehabilitation per session, including task-specific training, strengthening, and mobility exercises. Therapy duration is matched to the intervention group. Outcomes assessor is blinded. |
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| Stroke Survivors (Vibration Therapy on Upper or Lower Limb) | Experimental | Stroke survivors receive 20 minutes of precision vibration therapy applied to the affected upper or lower limb followed by 40 minutes of conventional rehabilitation per session (total 60 minutes). Intervention aims to improve muscle strength, proprioception, and functional outcomes. Outcomes assessor is blinded. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Vibration Therapy | Device | Precision vibration therapy applied to either the upper or lower limb, depending on participant's functional deficit. Each session includes 20 minutes of vibration followed by 40 minutes of conventional rehabilitation (total 60 minutes). The vibration device delivers controlled frequency and amplitude for neuromuscular activation, proprioceptive enhancement, and functional improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment (FMA) Score | The Fugl-Meyer Assessment evaluates motor recovery after stroke, including upper and lower extremity motor performance, coordination, and reflex activity. Higher scores indicate better motor function. | Baseline and Week 8 (end of intervention) |
| Motor Assessment Scale (MAS) Score | The Motor Assessment Scale measures functional motor performance across multiple daily activities in stroke patients. Higher scores indicate better motor ability. | Baseline and Week 8 (end of intervention) |
| Maximal Voluntary Contraction (MVC) Force | Maximal voluntary contraction of major lower-limb muscles will be measured using isometric dynamometry to assess muscle strength changes. | Baseline and Week 8 (end of intervention) |
| Muscle Force Stability | Muscle force steadiness during submaximal contraction tasks will be quantified to evaluate neuromuscular control and stability. | Baseline and Week 8 (end of intervention) |
| Surface Electromyography (EMG) Activity | Surface EMG recordings from target muscles will be used to analyze muscle activation patterns, coordination, and fatigue characteristics. | Baseline and Week 8 (end of intervention) |
| Pain Intensity (Visual Analog Scale, VAS) | Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS), where higher scores indicate greater pain severity. | Baseline and Week 8 (end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Manual Dexterity Test (MMDT) Performance | The Minnesota Manual Dexterity Test assesses manual dexterity and coordination of the upper limbs. Performance time (seconds) is recorded; shorter completion times indicate better dexterity. | Baseline and Week 8 (end of intervention) |
| Joint Proprioception (Active and Passive Position Sense) |
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Inclusion Criteria:
Older Adults:
Stroke Survivors:
Exclusion Criteria:
Older Adults:
Stroke Survivors:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Po-Jung Chen, Ph.D. | Contact | +886-5-632-5080 | 17 | pojungchen@nhri.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Geriatrics and Welfare Research, National Health Research Institutes | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This project consists of two independent parallel sub-studies targeting different populations:
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The outcomes assessor will be blinded to participants' group allocation to reduce assessment bias.
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| Conventional Rehabilitation | Other | Conventional rehabilitation therapy including task-specific training, strengthening, mobility, and balance exercises. Each session lasts 60 minutes. The therapy protocol is standardized across study sites and matched in duration and therapist contact time to the vibration therapy arms. |
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| Functional Performance and Quality of Life | Functional ability and perceived quality of life will be assessed using validated scales including the Barthel Index (BI), Instrumental Activities of Daily Living (IADL), and SF-36 Health Survey. | Baseline and Week 8 (end of intervention) |
| 6-Minute Walk Test (6MWT) Distance | The 6MWT measures functional endurance and walking capacity. Total distance walked in six minutes is recorded; longer distance indicates improved endurance. | Baseline and Week 8 (end of intervention) |
| 10-Meter Walk Test (10MWT) Speed | The 10MWT assesses gait speed and mobility. Average walking speed (m/s) over a 10-meter distance is calculated, with faster speeds indicating improved functional mobility. | Baseline and Week 8 (end of intervention) |
| 30-Second Chair Stand Test Performance | The 30-Second Chair Stand Test measures lower-limb strength and endurance by counting the number of full stands completed in 30 seconds. Higher counts indicate better performance. | Baseline and Week 8 (end of intervention) |
| Functional Reach Test Distance | The Functional Reach Test assesses dynamic balance by measuring the maximum forward reach distance while maintaining a fixed base of support. Greater reach distance indicates better balance control. | Baseline and Week 8 (end of intervention) |
Measures active and passive joint position sense at upper and/or lower limb joints using standard proprioceptive testing procedures. Lower error angles indicate improved proprioceptive acuity. |
| Baseline and Week 8 (end of intervention) |
| Coordination Control (Bimanual Grip and Bilateral Ankle Coordination Tests) | Coordination tests include bilateral grip control and bilateral ankle coordination tasks to evaluate interlimb coordination and control precision. | Baseline and Week 8 (end of intervention) |
| Barthel Index (BI) Score | The Barthel Index assesses activities of daily living (ADL) independence, including feeding, bathing, dressing, mobility, and toileting. Higher scores indicate greater functional independence. | Baseline and Week 8 (end of intervention) |
| Wolf Motor Function Test (WMFT) Score | The WMFT evaluates upper extremity motor function through timed and functional tasks. Lower time scores and higher functional ratings represent better motor performance. | Baseline and Week 8 (end of intervention) |
| Berg Balance Scale (BBS) Score | The BBS assesses static and dynamic balance using 14 tasks. Total scores range from 0 to 56, with higher scores representing better balance. | Baseline and Week 8 (end of intervention) |
| Timed Up and Go (TUG) Test Performance | The TUG test measures mobility and dynamic balance by recording the time taken to stand from a chair, walk 3 meters, turn, return, and sit. Shorter times indicate improved mobility. | Baseline and Week 8 (end of intervention) |
| Function (Spatiotemporal Parameters) | Gait performance parameters (e.g., gait speed, stride length, cadence, and symmetry) will be assessed to evaluate locomotor function improvement. | Baseline and Week 8 (end of intervention) |
| Pain-Related Outcomes (BPI, PADT, PDI, NPRS) | Pain characteristics and interference will be assessed using the Brief Pain Inventory (BPI), Pain Assessment and Documentation Tool (PADT), Pain Disability Index (PDI), and Numeric Pain Rating Scale (NPRS). | Baseline and Week 8 (end of intervention) |
| WOMAC Osteoarthritis Index | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will evaluate pain, stiffness, and physical function related to knee discomfort. | Baseline and Week 8 (end of intervention) |
| Quantitative Sensory Testing (QST) Results | Quantitative sensory testing will be used to assess somatosensory function, including pain threshold and sensitivity. | Baseline and Week 8 (end of intervention) |
| Quality of Life (QOL and SF-36) | Overall quality of life and health-related well-being will be assessed using the Quality of Life Questionnaire (QOL) and SF-36 Health Survey. | Baseline and Week 8 (end of intervention) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |