About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet two or more criteria of the Study of Osteoporotic Fractures (SOF) frailty index
Willing to participate in the study and comply with all study procedures
Able to wear and safely use the vibration device
Normal cognitive function (Mini-Mental State Examination [MMSE] score ≥ 23)
Disqualifiers
Acute or chronic neurological injury involving the upper or lower limbs within the past 6 months
Acute or chronic musculoskeletal injury involving the upper or lower limbs within the past 6 months
History of surgery on the upper or lower limbs within the past 6 months
Recurrent stroke during the current episode (i.e., acute re-stroke) or otherwise clinically unstable stroke presentation
Trial design
Parallel
Treatments tested in this trial
Precision Vibration Therapy
DevicePrecision 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
Other interventionConventional 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Maximal Voluntary Contraction (MVC) Force
Maximal voluntary contraction of major lower-limb muscles will be measured using isometric dynamometry to assess muscle strength changes.
Muscle Force Stability
Muscle force steadiness during submaximal contraction tasks will be quantified to evaluate neuromuscular control and stability.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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