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

NCT07351877 | Recruiting

• 1 other identifier: EC1130707-E
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Stroke

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (12)

• Minnesota Manual Dexterity Test (MMDT) Performance

  Baseline and Week 8 (end of intervention)

• Joint Proprioception (Active and Passive Position Sense)

  Baseline and Week 8 (end of intervention)

• Coordination Control (Bimanual Grip and Bilateral Ankle Coordination Tests)

  Baseline and Week 8 (end of intervention)

• Barthel Index (BI) Score

  Baseline and Week 8 (end of intervention)

• Wolf Motor Function Test (WMFT) Score

  Baseline and Week 8 (end of intervention)

Study Arms (4)

Older Adults (Conventional Rehabilitation)

ACTIVE COMPARATOR

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

Older Adults (Vibration Therapy on Upper or Lower Limb)

EXPERIMENTAL

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

Stroke Survivors (Conventional Rehabilitation)

ACTIVE COMPARATOR

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

Stroke Survivors (Vibration Therapy on Upper or Lower Limb)

EXPERIMENTAL

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

Interventions

Precision Vibration Therapy DEVICE

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.

Older Adults (Vibration Therapy on Upper or Lower Limb); Stroke Survivors (Vibration Therapy on Upper or Lower Limb)

Conventional Rehabilitation OTHER

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.

Older Adults (Conventional Rehabilitation); Stroke Survivors (Conventional Rehabilitation)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

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

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Po-Jung Chen, Ph.D.

CONTACT

+886-5-632-5080; pojungchen@nhri.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to participants' group allocation to reduce assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project consists of two independent parallel sub-studies targeting different populations: 1. older adults without stroke and 2. stroke survivors (≥18 years, any age). Each sub-study uses a randomized parallel-group design comparing vibration therapy (upper or lower limb) versus conventional rehabilitation. The two populations will not be enrolled concurrently in the same study phase.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: September 18, 2024
• Primary Completion (Estimated): December 18, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-09

Locations

TW (1)