A Study of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for Stroke (nBETTER)
A Pilot Feasibility Clinical Trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for postStroke Arm Paresis
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Stroke remains the 4th cause of death in Singapore and despite advances in neuro-medical care and rehabilitation, 40-50% of stroke survivors are left with permanent neuro-disability and a reduced quality of life. The previous 2 decades has seen exponential leaps in the development of rehabilitation technologies which enhance neuroplasticity and rehabilitation outcome. One of these potentially useful technologies is nBETTER System, was developed by Institute for Infocomm Research, Agency for Science, Technology and Research (A*STAR). nBETTER is a portable, internet-connected device that detects the imagination of movement of stroke-affected limb using a Electroencephalography (EEG)-based Brain-Computer Interface (BCI) thus delivering visually engaging feedback for directed neurofeedback aimed at improving upper limb recovery for subacute to chronic stroke patients. The pilot study aims to recruit 13 patients using a multi centre trial design to investigate nBETTER system feasibility and safety for rehabilitation of subacute to chronic stroke patients with upper limb motor impairment and to determine clinical efficacy, safety and feasibility of such a system when it is delivered with standard occupational therapy.
The investigators primary hypothesis is that nBETTER is a feasible and safe prototype in stroke survivors (> 3 months) with moderate to severe arm impairment (FMMA 10-50). The primary outcome is a gain of 15% in Fugl-Meyer motor scores at 6 weeks after 18 sessions (total of 27 hours) of supervised training by occupational therapists and bioengineers.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Singapore, Singapour, 308433
- Tan Tock Seng Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Aged 21-80 years with first-ever clinical stroke diagnosed on CT or MRI brain imaging.
- Stroke duration of 3-24 months.
- Stroke type: ischemic or haemorrhagic
- Fugl-Meyer motor score of the upper limb range from 10-50
- Ability to pay attention and maintain supported sitting for 1.5 hours continuously
- Able to give own consent and understand simple instructions
- Fulfils BCI resting brain states on initial screening.
Exclusion Criteria:
- Recurrent clinical stroke
- Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder)
- Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids
- History of epilepsy, severe depression or active psychiatric disorder
- Skull defect or previous cranial surgery as this would affect physical fit of EEG cap interface
- Local arm factors: severe spasticity Modified Ashworth scale >2 in any region, visual analogue scale (VAS score) >4/10, fixed joint contractures or joint replacements, patients with poor skin conditions which would contraindicate repetitive arm training.
- TMS contraindications: females with reproductive potential not on reliable contraception; pregnancy; cardiac pacemakers; orthodontics (braces); metal implants.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Faisabilité de l'appareil
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: nBETTER and Conventional Therapy
Intervention: nBetter therapy
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60 minutes of nBETTER training followed by 30 minutes of conventional therapy occupational therapy.
Total of 18 sessions over 6 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Upper extremity Fugl-Meyer motor score post training
Délai: Baseline and week 6
|
As above
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Baseline and week 6
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Transcranial Magnetic Stimulation Assessment (TMS)
Délai: Baseline and week 6
|
As above
|
Baseline and week 6
|
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Change in Grip Strength
Délai: Baseline and week 6
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Grip Strength measures hand force in kgf
|
Baseline and week 6
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Change in Frenchay Arm Test of Function (FAT)
Délai: Baseline and week 6
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Frenchay Arm Test of Function (FAT) measures 5 tasks:
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Baseline and week 6
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Change in Modified Ashworth Scale score (MAS)
Délai: Baseline and week 6
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Modified Ashworth Scale score (MAS) measure spasticity of wrist and hand finger flexors on a scale from 0 to 4
|
Baseline and week 6
|
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Change in Visual Analogue Scale (VAS)
Délai: Baseline and week 6
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Visual Analogue Scale (VAS) measures pain on a scale from 0 to 10
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Baseline and week 6
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Karen S Chua, MBBS, FRCP, Tan Tock Seng Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
- 2014/01164
Plan pour les données individuelles des participants (IPD)
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