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

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

Overview

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.

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.

Primary outcome measures

• Fugl-Meyer Assessment (FMA) Score [Time frame: Baseline and Week 8 (end of intervention)]
• Motor Assessment Scale (MAS) Score [Time frame: Baseline and Week 8 (end of intervention)]
• Maximal Voluntary Contraction (MVC) Force [Time frame: Baseline and Week 8 (end of intervention)]
• Muscle Force Stability [Time frame: Baseline and Week 8 (end of intervention)]
• Surface Electromyography (EMG) Activity [Time frame: Baseline and Week 8 (end of intervention)]
• Pain Intensity (Visual Analog Scale, VAS) [Time frame: Baseline and Week 8 (end of intervention)]
• Functional Performance and Quality of Life [Time frame: Baseline and Week 8 (end of intervention)]
• 6-Minute Walk Test (6MWT) Distance [Time frame: Baseline and Week 8 (end of intervention)]
• 10-Meter Walk Test (10MWT) Speed [Time frame: Baseline and Week 8 (end of intervention)]
• 30-Second Chair Stand Test Performance [Time frame: Baseline and Week 8 (end of intervention)]

Secondary outcome measures (12)

• Minnesota Manual Dexterity Test (MMDT) Performance [Time frame: Baseline and Week 8 (end of intervention)]
• Joint Proprioception (Active and Passive Position Sense) [Time frame: Baseline and Week 8 (end of intervention)]
• Coordination Control (Bimanual Grip and Bilateral Ankle Coordination Tests) [Time frame: Baseline and Week 8 (end of intervention)]
• Barthel Index (BI) Score [Time frame: Baseline and Week 8 (end of intervention)]
• Wolf Motor Function Test (WMFT) Score [Time frame: Baseline and Week 8 (end of intervention)]
• Berg Balance Scale (BBS) Score [Time frame: Baseline and Week 8 (end of intervention)]
• Timed Up and Go (TUG) Test Performance [Time frame: Baseline and Week 8 (end of intervention)]
• Function (Spatiotemporal Parameters) [Time frame: Baseline and Week 8 (end of intervention)]
• Pain-Related Outcomes (BPI, PADT, PDI, NPRS) [Time frame: Baseline and Week 8 (end of intervention)]
• WOMAC Osteoarthritis Index [Time frame: Baseline and Week 8 (end of intervention)]
• Quantitative Sensory Testing (QST) Results [Time frame: Baseline and Week 8 (end of intervention)]
• Quality of Life (QOL and SF-36) [Time frame: Baseline and Week 8 (end of intervention)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• National Center for Geriatrics and Welfare Research, National Health Research Institutes — Taipei

Identifiers

NCT: NCT07351877 · EC1130707-E

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗