Task-Oriented Upper Limb Training With Focal Vibration in Stroke
23 avril 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
38
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jisu Kim, PT
- Numéro de téléphone: +82-10-8362-6639
- E-mail: ksuu6639@naver.com
Lieux d'étude
-
-
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Seoul, Corée du Sud
- Recrutement
- Cheongdam Hospital
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Contact:
- Jisu Kim, PT
- Numéro de téléphone: +82-10-8362-6639
- E-mail: ksuu6639@naver.com
-
Seoul, Corée du Sud
- Pas encore de recrutement
- Sahmyook University
-
Contact:
- Jisu Kim, PT
- Numéro de téléphone: +82-10-8362-6639
- E-mail: ksuu6639@naver.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Joint Position Sense (JPS)
Délai: 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.
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Baseline and immediately after 6 weeks of intervention
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Thumb Localization Test (TLT)
Délai: 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)
Délai: 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.
|
Baseline and immediately after 6 weeks of intervention
|
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Box and Block Test (BBT)
Délai: 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
|
Baseline and immediately after 6 weeks of intervention
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Modified Ashworth Scale (MAS)
Délai: 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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
27 avril 2026
Achèvement primaire (Estimé)
1 décembre 2026
Achèvement de l'étude (Estimé)
1 février 2027
Dates d'inscription aux études
Première soumission
23 avril 2026
Première soumission répondant aux critères de contrôle qualité
23 avril 2026
Première publication (Réel)
30 avril 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 avril 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 avril 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SU-PT-2026-01-018-002
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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