National Center for Geriatrics and Welfare Research, National Health Research Institutes
Taipei, Taiwan
Location status: Recruiting
NCT Number: NCT07351877
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.
Interested in participating?
Request Info18 year–95 year
All sexes
Interventional
Not applicable
Taipei, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Older Adults:
Stroke Survivors:
Exclusion criteria
Older Adults:
Stroke Survivors:
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.
Time frame: Baseline and Week 8 (end of intervention)
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)
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 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 steadiness during submaximal contraction tasks will be quantified to evaluate neuromuscular control and stability.
Time frame: Baseline and Week 8 (end of intervention)
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 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 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)
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)
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)
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)
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)
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)
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 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)
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)
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)
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)
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.
Time frame: Baseline and Week 8 (end of intervention)
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 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)
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 will be used to assess somatosensory function, including pain threshold and sensitivity.
Time frame: Baseline and Week 8 (end of intervention)
Overall quality of life and health-related well-being will be assessed using the Quality of Life Questionnaire (QOL) and SF-36 Health Survey.
Contact information is provided by the study sponsor or research team.
National Health Research Institutes, Taiwan
Other
Exploring the Clinical Benefits of Precision Vibration on Neuromuscular Induction, Proprioceptive Gain, Functional Enhancement, and Pain Relief in Older Adults and and Stroke Survivors
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