StrokeNCT07558876
Task-Oriented Upper Limb Training With Focal Vibration in Stroke
A study testing Task-oriented upper limb training combined with focal vibration and Active Comparator: Task-Oriented Upper Limb Training Alone in people with Stroke, run by Jisu Kim at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Task-oriented upper limb training combined with focal vibration and Active Comparator: Task-Oriented Upper Limb Training Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 27 Apr 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Cheongdam Hospital
Seoul
Jisu Kim, PT, +82-10-8362-6639, ksuu6639@naver.com
- Not yet recruiting
Sahmyook University
Seoul
Jisu Kim, PT, +82-10-8362-6639, ksuu6639@naver.com
About this study
Official title: Effects of Task-Oriented Upper Limb Training With Localized Vibration on Hand Function, Proprioception, and Muscle Tone in Patients With 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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Task-oriented upper limb training combined with focal vibration, Active Comparator: Task-Oriented Upper Limb Training Alone
- Keywords
- Stroke, Upper Limb Rehabilitation, Task-Oriented Training, Hand Function, Focal Vibration, Proprioception, Muscle Tone
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented upper limb training combined with focal vibrationProcedure or surgery
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 AloneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Task-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. Receives: Procedure: Active Comparator: Task-Oriented Upper Limb Training Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after 6 weeks of intervention
Secondary outcomes (5)
Joint Position Sense (JPS)
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.
Measured: Baseline and immediately after 6 weeks of intervention
Thumb Localization Test (TLT)
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.
Measured: Baseline and immediately after 6 weeks of intervention
Action Research Arm Test (ARAT)
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.
Measured: Baseline and immediately after 6 weeks of intervention
Box and Block Test (BBT)
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
Measured: Baseline and immediately after 6 weeks of intervention
Modified Ashworth Scale (MAS)
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.
Measured: Baseline and immediately after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start27 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jisu Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jisu Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558876
- Sponsor's protocol ID
- SU-PT-2026-01-018-002
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task-Oriented Upper Limb Training With Localized Vibration on Hand Function, Proprioception, and Muscle Tone in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07558876
- Acronym / sponsor ID
- SU-PT-2026-01-018-002
- Conditions
- Stroke
- Keywords
- Stroke, Upper Limb Rehabilitation, Task-Oriented Training, Hand Function, Focal Vibration, Proprioception, Muscle Tone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Jisu KimUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Task-Oriented Upper Limb Training with Focal Vibration | Experimental | Procedure: Task-oriented upper limb training combined with focal vibrationParticipants 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. |
| Task-Oriented Upper Limb Training Alone | Active comparator | Procedure: Active Comparator: Task-Oriented Upper Limb Training AloneParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-oriented upper limb training combined with focal vibrationParticipants 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. | Procedure or surgery | Task-Oriented Upper Limb Training with Focal Vibration |
| Active Comparator: Task-Oriented Upper Limb Training AloneParticipants 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. | Procedure or surgery | Task-Oriented Upper Limb Training Alone |
Primary outcome
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.
5 secondary outcomes
Joint Position Sense (JPS)
Time frame: Baseline and immediately after 6 weeks of intervention
Thumb Localization Test (TLT)
Time frame: Baseline and immediately after 6 weeks of intervention
Action Research Arm Test (ARAT)
Time frame: Baseline and immediately after 6 weeks of intervention
Box and Block Test (BBT)
Time frame: Baseline and immediately after 6 weeks of intervention
Modified Ashworth Scale (MAS)
Time frame: Baseline and immediately after 6 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented upper limb training combined with focal vibration and Active Comparator: Task-Oriented Upper Limb Training Alone in people with Stroke, run by Jisu Kim at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jisu Kim, PT (+82-10-8362-6639, ksuu6639@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) (time frame: Baseline and immediately after 6 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.