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临床试验/NCT07351877
NCT07351877招募中不适用

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 个研究点目标入组 80 人开始时间: 2024年9月18日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
National Health Research Institutes, Taiwan
申办方类型
Other
责任方
Sponsor

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