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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Aging
• Intervention / Treatment: Other: Conventional Rehabilitation; Device: Precision Vibration Therapy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Po-Jung Chen, Ph.D.; Phone Number: 17 +886-5-632-5080; Email: pojungchen@nhri.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Center for Geriatrics and Welfare Research, National Health Research Institutes
    • Contact: Po-Jung Chen, Ph.D.; Phone Number: 17 +886-5-632-5080; Email: pojungchen@nhri.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Older Adults (Conventional Rehabilitation); 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.	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.
Experimental: Older Adults (Vibration Therapy on Upper or Lower Limb); 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.	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.
Active Comparator: Stroke Survivors (Conventional Rehabilitation); 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.	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.
Experimental: Stroke Survivors (Vibration Therapy on Upper or Lower Limb); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 8 (end of intervention)
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.	Baseline and Week 8 (end of intervention)
Maximal Voluntary Contraction (MVC) Force	Maximal voluntary contraction of major lower-limb muscles will be measured using isometric dynamometry to assess muscle strength changes.	Baseline and Week 8 (end of intervention)
Muscle Force Stability	Muscle force steadiness during submaximal contraction tasks will be quantified to evaluate neuromuscular control and stability.	Baseline and Week 8 (end of intervention)
Surface Electromyography (EMG) Activity	Surface EMG recordings from target muscles will be used to analyze muscle activation patterns, coordination, and fatigue characteristics.	Baseline and Week 8 (end of intervention)
Pain Intensity (Visual Analog Scale, VAS)	Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS), where higher scores indicate greater pain severity.	Baseline and Week 8 (end of intervention)
Functional Performance and Quality of Life	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.	Baseline and Week 8 (end of intervention)
6-Minute Walk Test (6MWT) Distance	The 6MWT measures functional endurance and walking capacity. Total distance walked in six minutes is recorded; longer distance indicates improved endurance.	Baseline and Week 8 (end of intervention)
10-Meter Walk Test (10MWT) Speed	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.	Baseline and Week 8 (end of intervention)
30-Second Chair Stand Test Performance	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.	Baseline and Week 8 (end of intervention)
Functional Reach Test Distance	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.	Baseline and Week 8 (end of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 8 (end of intervention)
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.	Baseline and Week 8 (end of intervention)
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.	Baseline and Week 8 (end of intervention)
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.	Baseline and Week 8 (end of intervention)
Wolf Motor Function Test (WMFT) Score	The WMFT evaluates upper extremity motor function through timed and functional tasks. Lower time scores and higher functional ratings represent better motor performance.	Baseline and Week 8 (end of intervention)
Berg Balance Scale (BBS) Score	The BBS assesses static and dynamic balance using 14 tasks. Total scores range from 0 to 56, with higher scores representing better balance.	Baseline and Week 8 (end of intervention)
Timed Up and Go (TUG) Test Performance	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.	Baseline and Week 8 (end of intervention)
Function (Spatiotemporal Parameters)	Gait performance parameters (e.g., gait speed, stride length, cadence, and symmetry) will be assessed to evaluate locomotor function improvement.	Baseline and Week 8 (end of intervention)
Pain-Related Outcomes (BPI, PADT, PDI, NPRS)	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).	Baseline and Week 8 (end of intervention)
WOMAC Osteoarthritis Index	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will evaluate pain, stiffness, and physical function related to knee discomfort.	Baseline and Week 8 (end of intervention)
Quantitative Sensory Testing (QST) Results	Quantitative sensory testing will be used to assess somatosensory function, including pain threshold and sensitivity.	Baseline and Week 8 (end of intervention)
Quality of Life (QOL and SF-36)	Overall quality of life and health-related well-being will be assessed using the Quality of Life Questionnaire (QOL) and SF-36 Health Survey.	Baseline and Week 8 (end of intervention)

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): December 18, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: EC1130707-E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No