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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Singapore, 싱가포르, 308433
- Tan Tock Seng Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Upper extremity Fugl-Meyer motor score post training
기간: Baseline and week 6
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As above
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Baseline and week 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Transcranial Magnetic Stimulation Assessment (TMS)
기간: Baseline and week 6
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As above
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Baseline and week 6
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Change in Grip Strength
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Karen S Chua, MBBS, FRCP, Tan Tock Seng Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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