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

National Health Research Institutes, Taiwan

Status: Enrolling

Conditions: Aging; Stroke

Treatments: Other: Conventional Rehabilitation; Device: Precision Vibration Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07351877

EC1130707-E

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Older Adults (Conventional Rehabilitation)

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Rehabilitation

Older Adults (Vibration Therapy on Upper or Lower Limb)

Experimental group

Description:

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.

Treatment:

Device: Precision Vibration Therapy

Stroke Survivors (Conventional Rehabilitation)

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Rehabilitation

Stroke Survivors (Vibration Therapy on Upper or Lower Limb)

Experimental group

Description:

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.

Treatment:

Device: Precision Vibration Therapy