Task-Oriented Upper Limb Training With Focal Vibration in Stroke
23 aprile 2026 aggiornato da: Jisu Kim
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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
38
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jisu Kim, PT
- Numero di telefono: +82-10-8362-6639
- Email: ksuu6639@naver.com
Luoghi di studio
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Seoul, Corea del Sud
- Reclutamento
- Cheongdam Hospital
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Contatto:
- Jisu Kim, PT
- Numero di telefono: +82-10-8362-6639
- Email: ksuu6639@naver.com
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Seoul, Corea del Sud
- Non ancora reclutamento
- Sahmyook University
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Contatto:
- Jisu Kim, PT
- Numero di telefono: +82-10-8362-6639
- Email: ksuu6639@naver.com
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Task-Oriented Upper Limb Training with Focal Vibration
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.
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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.
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Comparatore attivo: Task-Oriented Upper Limb Training Alone
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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Lasso di tempo: Baseline and immediately after 6 weeks of intervention
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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.
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Baseline and immediately after 6 weeks of intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Joint Position Sense (JPS)
Lasso di tempo: Baseline and immediately after 6 weeks of intervention
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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.
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Baseline and immediately after 6 weeks of intervention
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Thumb Localization Test (TLT)
Lasso di tempo: Baseline and immediately after 6 weeks of intervention
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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.
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Baseline and immediately after 6 weeks of intervention
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Action Research Arm Test (ARAT)
Lasso di tempo: Baseline and immediately after 6 weeks of intervention
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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.
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Baseline and immediately after 6 weeks of intervention
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Box and Block Test (BBT)
Lasso di tempo: Baseline and immediately after 6 weeks of intervention
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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
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Baseline and immediately after 6 weeks of intervention
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Modified Ashworth Scale (MAS)
Lasso di tempo: Baseline and immediately after 6 weeks of intervention
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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.
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Baseline and immediately after 6 weeks of intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
27 aprile 2026
Completamento primario (Stimato)
1 dicembre 2026
Completamento dello studio (Stimato)
1 febbraio 2027
Date di iscrizione allo studio
Primo inviato
23 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
23 aprile 2026
Primo Inserito (Effettivo)
30 aprile 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 aprile 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SU-PT-2026-01-018-002
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .