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RECRUITING

NCT07351877

Precision Vibration Therapy for Neuromuscular and Functional Improvement in Older Adults and Stroke Survivors

Sponsor: National Health Research Institutes, Taiwan

View on ClinicalTrials.gov

Summary

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.

Official title: Exploring the Clinical Benefits of Precision Vibration on Neuromuscular Induction, Proprioceptive Gain, Functional Enhancement, and Pain Relief in Older Adults and and Stroke Survivors

Key Details

Gender

All

Age Range

18 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-09-18

Completion Date

2027-12-31

Last Updated

2026-01-20

Healthy Volunteers

Conditions

Aging Stroke

Interventions

DEVICE

Precision Vibration Therapy

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.

OTHER

Conventional Rehabilitation

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.

Inclusion Criteria: Older Adults: * 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) * Presence of knee joint pain in the lower limbs Stroke Survivors: * Clinical diagnosis of ischemic or hemorrhagic stroke confirmed by a physician * Clinically stable stroke condition (i.e., not in an acute or unstable phase) * Brunnstrom stage ≥ III for the affected limb * Cognitive ability sufficient to follow study procedures (MMSE score ≥ 23) * Modified Ashworth Scale (MAS) score \< 3 for the paretic limb * Able to sit safely and participate in vibration or rehabilitation sessions for up to 60 minutes per visit * Willing and able to comply with all study procedures and provide written informed consent Exclusion Criteria: Older Adults: * 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 Stroke Survivors: * Recurrent stroke during the current episode (i.e., acute re-stroke) or otherwise clinically unstable stroke presentation * Markedly elevated spasticity preventing isolated voluntary movement of the target limb (MAS score ≥ 3) * Hemianopsia or severe hemineglect that significantly interferes with task execution * Concomitant vestibular or cerebellar disorders that severely impair motor performance * Orthopedic or traumatic comorbidities causing significant pain or limiting safe participation during evaluation or intervention * Cognitive impairment attributable to stroke that precludes effective communication or adherence to the study protocol * Other neurological or psychiatric disorders judged likely to interfere with motor performance or study outcomes

Locations (1)

National Center for Geriatrics and Welfare Research, National Health Research Institutes

Taipei, Taiwan