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临床试验/NCT07558876
NCT07558876招募中不适用

Effects of Task-Oriented Upper Limb Training With Localized Vibration on Hand Function, Proprioception, and Muscle Tone in Patients With Stroke

Jisu Kim2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年4月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
38
试验地点
2
主要终点
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

研究概览

简要总结

This study aims to investigate the effects of task-oriented upper limb training combined with focal vibration on hand function, proprioception, and muscle tone in patients with stroke. Participants will be randomly assigned to either an experimental group receiving task-oriented training with concurrent focal vibration or a control group receiving task-oriented training alone. The intervention will be conducted over 6 weeks. Outcome measures will be assessed before and after the intervention.

详细描述

Stroke often results in impairments in upper limb function, including reduced motor control, altered muscle tone, and deficits in proprioception. These impairments can significantly limit functional use of the affected limb in daily activities.

Task-oriented training has been widely used in stroke rehabilitation to improve motor function through repetitive and goal-directed tasks. However, recovery may be limited when sensory input is insufficient. Enhancing sensory feedback, particularly proprioceptive input, may facilitate sensorimotor integration and improve functional outcomes.

Focal vibration applied to muscle or tendon has been shown to stimulate muscle spindle afferents, thereby enhancing proprioceptive input to the central nervous system. When applied during active task performance, focal vibration may further augment motor learning and functional recovery.

This study is designed as a randomized controlled trial to investigate the effects of task-oriented upper limb training combined with focal vibration. Participants will be randomly assigned to either an experimental group receiving task-oriented training with concurrent focal vibration applied to wrist extensor muscles or a control group receiving task-oriented training alone.

The intervention will be conducted for 6 weeks. Outcome measures will include upper limb motor function, proprioception, manual dexterity, and muscle tone, assessed before and after the intervention.

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
Single (Participant)

盲法说明

Participants will be blinded to group allocation.

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals diagnosed with stroke at least 3 months prior
  • •Individuals with sufficient cognitive function (Mini-Mental State Examination [MMSE] score ≥ 24)
  • •Individuals able to maintain a seated position independently and perform upper limb functional tasks (Trunk Control Test [TCT] ≥ 50)
  • •Individuals with muscle tone of the affected upper limb of Modified Ashworth Scale (MAS) Grade ≤ 2
  • •Individuals with Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores between 20 and 50
  • •Individuals able to grasp and move objects with the affected upper limb and with muscle strength of Manual Muscle Test (MMT) Grade ≥ 3
  • •Individuals with impaired proprioception in the affected hand (defined as a score < 2 on the wrist or thumb position item of the FMA-UE)

排除标准

  • •Individuals within 3 months after stroke onset
  • •Individuals with fractures, severe soft tissue injuries, or contraindications to focal vibration
  • •Individuals with severe sensory hypersensitivity or complex regional pain syndrome (CRPS)
  • •Individuals who received treatments affecting upper limb function within the past 3 months (e.g., botulinum toxin injection, surgery, nerve block)

研究组 & 干预措施

Task-Oriented Upper Limb Training with Focal Vibration

Experimental

Participants will receive task-oriented upper limb training combined with focal vibration applied to the wrist extensor muscles during task performance. The intervention will be conducted for 6 weeks, twice per week, with each session lasting 30 minutes. Each session will include functional tasks such as reaching, grasping, object manipulation, and wrist control exercises. Focal vibration will be applied only during active task execution to enhance proprioceptive input, improve hand function, and reduce muscle tone.

干预措施: ask-oriented upper limb training combined with focal vibration (Procedure)

Task-Oriented Upper Limb Training Alone

Active Comparator

Participants will receive the same task-oriented upper limb training without focal vibration for 6 weeks, twice per week, with each session lasting 30 minutes. Each session will include functional tasks such as reaching, grasping, object manipulation, and wrist control exercises. The vibration device will be attached to the wrist extensor muscles in the same manner as the experimental group, but no vibration will be applied.

干预措施: Active Comparator: Task-Oriented Upper Limb Training Alone (Procedure)

结局指标

主要结局

Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

时间窗: Baseline and immediately after 6 weeks of intervention

The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor function of the affected upper limb. The total score ranges from 0 to 66, with higher scores indicating better motor function.

次要结局

  • Joint Position Sense (JPS)(Baseline and immediately after 6 weeks of intervention)
  • Thumb Localization Test (TLT)(Baseline and immediately after 6 weeks of intervention)
  • Action Research Arm Test (ARAT)(Baseline and immediately after 6 weeks of intervention)
  • Box and Block Test (BBT)(Baseline and immediately after 6 weeks of intervention)
  • Modified Ashworth Scale (MAS)(Baseline and immediately after 6 weeks of intervention)

研究者

发起方
Jisu Kim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jisu Kim

Graduate Student, Department of Physical Therapy, Sahmyook University

Sahmyook University

研究点 (2)

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