fNIRS for Monitoring Cortical Activity in Stroke Recovery
Functional Near-infrared Spectroscopy (fNIRS) is an Ideal Tool to Monitor Cortical Brain Activity and Understand the Mechanism Underlying Recovery Following Stroke
This clinical trial aims to investigate the mechanisms of brain reorganization underlying motor recovery following end-effector (EE) and exoskeleton (Exo) robot-assisted hand training in individuals with stroke. Using functional near-infrared spectroscopy (fNIRS), the study will (1) investigate brain activation patterns during EE and Exo robot-assisted hand movements in healthy adults and individuals with stroke and (2) examine longitudinal changes in brain activation and motor recovery over a 6-week intervention.
For Part 1, a cross-sectional observational study will be conducted to examine brain activation using fNIRS while participants perform EE and Exo robot-assisted movements. Healthy adults and individuals with stroke will each perform one session of each type of robot-assisted movement.
For Part 2, an evaluator-blinded randomized controlled design will be used. Participants will be stratified based on the level of motor impairment and the side of the brain lesion and then randomly assigned to either the EE or Exo robot-assisted training group. Both groups will receive training 3 times per week, with each session lasting 60 minutes, for a total of 6 weeks. Each session will include 40 minutes of robot-assisted therapy and 20 minutes of functional training.
Outcome assessments will be conducted at four time points: prior to the intervention (baseline), mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up. These assessments will be used to evaluate motor recovery and longitudinal changes in brain function.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chieh_ling Yang
- Numéro de téléphone: 3058 03-2118800
- E-mail: chieh-ling.yang@cgu.edu.tw
Lieux d'étude
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Taoyuan, Taïwan, 333
- Recrutement
- Chang Gung Memorial Hospital
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Contact:
- Chieh-ling Yang
- Numéro de téléphone: 3058 03-2118800
- E-mail: chieh-ling.yang@cgu.edu.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Stroke participants
Inclusion Criteria:
- unilateral stroke onset ≥ 3 months
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56 - modified Ashworth scale ≤ 3 in proximal joints and modified Ashworth scale ≤ 2 in distal joints
- able to follow 2-step instructions
- without excessive spasticity in any of the UE joints.
Exclusion Criteria:
- orthopedic conditions affecting the arm/hand or other neurological conditions
- severe pain that prevents movement in the affected arm and hand
- implanted cardiac pacemakers and cardioverter-defibrillators
- osteoporosis, fracture, or severe ataxia
- unstable medical status
- participating in other rehabilitation or drug studies simultaneously
- receiving Botulinum toxin injections within 3 months
Healthy participants
- have no neurological conditions
- have no musculoskeletal disorders affecting the UE
Plan d'étude
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 |
|---|---|
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Expérimental: End-Effector (EE) robot-assisted training group
Robot-assisted therapy (EE system) and functional training
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Each group will receive intervention 3 times per week, 60 minutes per session, for a total duration of 6 weeks.
The intervention will consist of 40 minutes of robot-assisted therapy and 20 minutes of functional training.
For the robot-assisted therapy, participants will receive training using either the EE or EXO system according to group allocation.
The functional training component will be conducted without robotic assistance and will focus on task-oriented activities to facilitate the transfer of motor learning to functional performance.
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Expérimental: Exoskeleton (EXO) robot-assisted training group.
Robot-assisted therapy (EXO system) and functional training
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Each group will receive intervention 3 times per week, 60 minutes per session, for a total duration of 6 weeks.
The intervention will consist of 40 minutes of robot-assisted therapy and 20 minutes of functional training.
For the robot-assisted therapy, participants will receive training using either the EE or EXO system according to group allocation.
The functional training component will be conducted without robotic assistance and will focus on task-oriented activities to facilitate the transfer of motor learning to functional performance.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Task-related changes in oxyhemoglobin (HbO) concentration measured using functional near-infrared spectroscopy (fNIRS)
Délai: Assessments will be conducted at baseline, mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up.
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Cortical activation will be quantified as task-related changes in oxyhemoglobin (HbO) measured using functional near-infrared spectroscopy (fNIRS) during robot-assisted movements and upper extremity functional tasks (e.g., shoulder abduction, finger extension, and grasping).
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Assessments will be conducted at baseline, mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Chieh-ling Yang, Chang Gung University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202400386B0
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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