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Clinical Trials/NCT07351877
NCT07351877
Recruiting
Not Applicable

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

National Health Research Institutes, Taiwan0 sites80 target enrollmentStarted: September 18, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
National Health Research Institutes, Taiwan
Enrollment
80

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

The outcomes assessor will be blinded to participants' group allocation to reduce assessment bias.

Eligibility Criteria

Ages
18 Years to 95 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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

Investigators

Sponsor
National Health Research Institutes, Taiwan
Sponsor Class
Other
Responsible Party
Sponsor

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