Task-Oriented Upper Limb Training With Focal Vibration in Stroke
23. April 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
38
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Jisu Kim, PT
- Telefonnummer: +82-10-8362-6639
- E-Mail: ksuu6639@naver.com
Studienorte
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Seoul, Südkorea
- Rekrutierung
- Cheongdam Hospital
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Kontakt:
- Jisu Kim, PT
- Telefonnummer: +82-10-8362-6639
- E-Mail: ksuu6639@naver.com
-
Seoul, Südkorea
- Noch keine Rekrutierung
- Sahmyook University
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Kontakt:
- Jisu Kim, PT
- Telefonnummer: +82-10-8362-6639
- E-Mail: ksuu6639@naver.com
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Joint Position Sense (JPS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
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Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
27. April 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2026
Studienabschluss (Geschätzt)
1. Februar 2027
Studienanmeldedaten
Zuerst eingereicht
23. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
23. April 2026
Zuerst gepostet (Tatsächlich)
30. April 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
30. April 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SU-PT-2026-01-018-002
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NEIN
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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