Task-Oriented Upper Limb Training With Focal Vibration in Stroke

NCT07558876 | Recruiting

• 1 other identifier: SU-PT-2026-01-018-002
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Upper Limb Rehabilitation; Task-Oriented Training; Hand Function; Focal Vibration; Proprioception; Muscle Tone

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and immediately after 6 weeks of intervention

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

Procedure: ask-oriented upper limb training combined with focal vibration

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.

Procedure: Active Comparator: Task-Oriented Upper Limb Training Alone

Interventions

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.

Task-Oriented Upper Limb Training with Focal Vibration

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.

Task-Oriented Upper Limb Training Alone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jisu Kim: lead

Study Sites (2)

Cheongdam Hospital

Seoul, South Korea

RECRUITING

Sahmyook University

Seoul, South Korea

NOT YET 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

Jisu Kim, PT

CONTACT

+82-10-8362-6639; ksuu6639@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate Student, Department of Physical Therapy, Sahmyook University

Model Details: Participants will be randomly assigned to either an experimental group receiving task-oriented upper limb training combined with focal vibration or a control group receiving task-oriented upper limb training alone.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)