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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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.
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.
National Center for Geriatrics and Welfare Research, National Health Research Institutes
Taipei, Taiwan
RECRUITINGFugl-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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 8 (end of intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 8 (end of intervention)
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.
Time frame: Baseline and Week 8 (end of intervention)
Joint Proprioception (Active and Passive Position Sense)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 8 (end of intervention)