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
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Singapore, Singapur, 308433
- Tan Tock Seng Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Machbarkeit des Geräts
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Upper extremity Fugl-Meyer motor score post training
Zeitfenster: Baseline and week 6
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As above
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Baseline and week 6
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Transcranial Magnetic Stimulation Assessment (TMS)
Zeitfenster: Baseline and week 6
|
As above
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Baseline and week 6
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Change in Grip Strength
Zeitfenster: Baseline and week 6
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Grip Strength measures hand force in kgf
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Baseline and week 6
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Change in Frenchay Arm Test of Function (FAT)
Zeitfenster: 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)
Zeitfenster: 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
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Baseline and week 6
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Change in Visual Analogue Scale (VAS)
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Karen S Chua, MBBS, FRCP, Tan Tock Seng Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2014/01164
Plan für individuelle Teilnehmerdaten (IPD)
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