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NCT Number: NCT07558876

Task-Oriented Upper Limb Training With Focal Vibration in Stroke

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheongdam Hospital, Seoul, South Korea

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About this study

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.

The findings of this study may provide evidence for the effectiveness of combining focal vibration with task-oriented training to enhance upper limb recovery in patients with stroke.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

ask-oriented upper limb training combined with focal vibration

Procedure

Participants in the experimental group will receive task-oriented upper limb training combined with focal vibration applied to the wrist extensor muscles during task performance. The intervention will be administered for 30 minutes per session, 2 times per week, for 6 weeks, and no vibration will be applied during rest periods.

Active Comparator: Task-Oriented Upper Limb Training Alone

Procedure

Participants in the control group will receive task-oriented upper limb training without the application of focal vibration, with the device attached to the wrist extensor muscles. The intervention will be administered for 30 minutes per session, 2 times per week, for 6 weeks.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Joint Position Sense (JPS)

    Time frame: Baseline and immediately after 6 weeks of intervention

    Joint position sense (JPS) will be assessed using an electronic goniometer by measuring the absolute error between a target joint angle and the reproduced angle. Lower error values indicate better proprioceptive function.

  2. Thumb Localization Test (TLT)

    Time frame: Baseline and immediately after 6 weeks of intervention

    The Thumb Localization Test (TLT) will be used to assess proprioceptive function of the affected upper limb. Participants will be asked to locate and grasp the thumb of the affected hand with the unaffected hand while their eyes are closed. Performance will be scored on a 4-point scale, with higher scores indicating greater impairment.

  3. Action Research Arm Test (ARAT)

    Time frame: Baseline and immediately after 6 weeks of intervention

    The Action Research Arm Test (ARAT) will be used to assess upper limb functional ability. The test consists of 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Each item is scored on a 4-point scale (0-3), with a total score ranging from 0 to 57. Higher scores indicate better upper limb function.

  4. Box and Block Test (BBT)

    Time frame: Baseline and immediately after 6 weeks of intervention

    The Box and Block Test (BBT) will be used to assess gross manual dexterity of the affected upper limb. Participants will be instructed to move as many blocks as possible from one compartment of a box to another within 60 seconds. The score is the number of blocks transferred, with higher scores indicating better manual dexterity

  5. Modified Ashworth Scale (MAS)

    Time frame: Baseline and immediately after 6 weeks of intervention

    The Modified Ashworth Scale (MAS) will be used to assess muscle tone of the affected upper limb. Spasticity is graded on a 6-point scale ranging from 0 to 4, including a 1+ grade, with higher scores indicating greater spasticity.

Study contacts

Contact information is provided by the study sponsor or research team.

Jisu Kim, PT

CONTACT

[email protected]

+82-10-8362-6639

Sponsors and collaborators

Lead sponsor

Jisu Kim

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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