Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation

Официальное название

Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation: A 3-arm Randomized Controlled Trial

Обзор

Upper extremity (UE) recovery remains a huge rehabilitation challenge with largely incomplete recovery of the upper limb post stroke. This is due to heavier priorities placed on other stroke competencies such as mobility, activities of daily living training and home integration which results in suboptimal amounts of time spent in upper limb training post stroke. In this study the investigators plan to pilot brain computer interface (BCI) integrated wearable hand robotic glove (HandyRehab) system for upper limb stroke rehabilitation.

Подробное описание

Robot-aided therapy have shown promising results in rehabilitation recovery in stroke patients while reducing strain and effort for both the therapist and suitable patients.

HandyRehab (HR) is a portable, wearable hand robotic glove used for functional training. The integration of Brain Computer Interface (BCI) platform with HR provides an alternative way of communication or intended movement through end-effectors for stroke and potentially facilitate neuroplasticity, improving motor functions.

This study aims to validate the usability of intensive training with HandyRehab (HR) compared with conventional occupational therapy (CT). Feasibility and safety of the novel BCI-HR will be examined and objective measures of clinical efficacy will be compared across all 3 platforms.

Вмешательства

• Устройство Brain Computer Interface integrated HandyRehab platform (BCI-HR)
  To test the usability, safety and efficacy of an experimental prototype of a wearable hand robotic glove integrated with brain computer interface system being developed and researched.
• Устройство HandyRehab (HR)
  A wearable hand robotic glove approved by Health Sciences Authority, class I commercial device
• Другое Standard Treatment of Care
  Standard Conventional Occupational Therapy

Первичные конечные точки

• Action Research Arm Test (ARAT) Score [Срок оценки: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]

Вторичные конечные точки (12)

• Fugl-Meyer Motor Assessment (FMA) scale [Срок оценки: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Grip Strength (kg) [Срок оценки: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Box and Block Test (BBT) [Срок оценки: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Nine Hole Peg Test (NHPT) [Срок оценки: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Self-efficacy outcomes by UPSET (upper limb self-efficacy test) [Срок оценки: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale) [Срок оценки: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Patient reported Outcome Measures (PROMs) using subjective scales (Likert 0-5) [Срок оценки: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Montreal Cognitive Assessment (MOCA) [Срок оценки: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]
• Rey Auditory Verbal Learning Test (RAVLT) [Срок оценки: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]
• Trail Making Test (TMT) [Срок оценки: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]
• Digit Span [Срок оценки: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]
• Controlled Oral Word Association Test (COWAT) [Срок оценки: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]

Критерии участия

Критерии включения

• Age 21-85 years, males and females
• First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist/neurosurgeon/CT/MRI imaging
• > 16 weeks post stroke
• Hemiplegic pattern of post-stroke weakness
• MRC ≥ 2/5 motor power and above for shoulder abduction \& elbow flexion
• MRC 0 to 4/5 motor power and above for finger flexors \&/or extensors of thumb, index, middle fingers
• Screening Fugl-Meyer wrist hand sub score <18/24
• Spasticity MAS <3 for thumb, index, and middle fingers
• Able to discriminate thumb and index sensation to pain
• Hand sizes within 170-200mm (length) \&75-85mm (width), compatible with HandyRehab robotic glove
• BCI compatible brain states using a standardised screening protocol
• Able to understand simple commands with Mini Mental state examination scores MMSE > 21/30)
• Able to give informed consent

• Subjects who are unable to clear BCI screening 11. will be randomised to either CT or HR groups.

Критерии исключения

Neurological

• Recurrent stroke
• Diagnosis of neurodegenerative disease; e.g. Parkinson's' disease, Dementia, ALS

Medical:

\- unstable medical or neurological conditions, life expectancy <6 months, end-organ renal failure on dialysis, severe heart failure, postural hypotension, history of uncontrolled sepsis, epilepsy with seizure within 3 months of informed consent, skin conditions which could potentially be worsened by wearable robot (ulcers, open wounds, eczema, infections etc)

Postural:

• Unable to tolerate upright posture or sit unaided for < 90min with rest breaks
• Cognitive/behavioural/visual:
• Severe dysphasia/aphasia, severe visual neglect/blindness, untreated severe depression, psychiatric illness, unable to understand study requirements

Upper limb:

• Moderate to severe spasticity (Modified Ashworth scale MAS ≥2)
• Hand/arm related pain (VAS Pain ≥ 5/10),
• Presence of finger contractures, reduced functional range of motion, limiting functional wrist/finger movements, active fractures or arthritis with deformities
• Severe limb ataxia/apraxia
• Severe post stroke hemi-anaesthesia in affected UE

BCI incompatibility:

• Motor imagery EEG signals unable to be detected
• Presence of craniectomy skull defect (affecting BCI cap fit and electrode contact)
• Concomitant participation in other interventional research trials
• Resident of nursing home or overseas country which may compromise attendance at research site
• Pregnant or lactating females will not be allowed to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Tan Tock Seng Hospital — Singapore

Идентификаторы

NCT: NCT06076928 · DSRB 2022/00694

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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