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临床试验/NCT03277508
NCT03277508已完成不适用

Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年3月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Action Research Arm Test

研究概览

简要总结

This research aims to integrate and develop a novel Brain-Computer Interface (BCI) controlled soft robotic glove, evaluate the ability of the glove in achieving common hand grasping postures and to assess the efficacy of the glove in assisting stroke patients with completing functional tasks. The BCI-controlled soft robotic glove utilizes patients' user intent to deliver specific electroencephalographic patterns that can trigger robot-assisted hand movement to the affected hand.

详细描述

Hand motor impairment is very common after a stroke. These impairments include difficulty moving and coordinating the hands and fingers, which inhibits stroke patients from being able to perform daily functional tasks independently, resulting in a reduced quality of life. More than half of people with upper limb impairment after stroke will still have problems many months to years after their stroke. Therefore, improving hand function is a core element of rehabilitation. Many possible interventions have been developed; these may involve different exercises or training, specialist equipment or techniques, or they could take the form of a drug (pill or injection) given to help hand movement. There is limited evidence that suggests the following interventions may be effective: constraint-induced movement therapy, mental practice, mirror therapy,interventions for sensory impairment, virtual reality and a relatively high dose of repetitive task practice. Current hand rehabilitation robotic devices are typically driven by rigid linkages or joints, which subject the patient's fingers into a single plane of motion that will feel unnatural and uncomfortable. On top of that,these devices belong to the class of continuous passive motion (CPM) devices that only promote hand range-of-motion, but do not require the patient to play a semi-active role in performing the hand exercises. Furthermore, there is a huge demand for solutions assisting stroke patients with using the densely paralyzed hand to perform activities of daily living (ADL) in real life, which is not available at present. Most of the hand rehabilitation robotic devices available in the market cannot assist paralyzed hand to carry out ADL. To develop an assistive device to solve this unmet need, we decided to combine BCI technology with the wearable soft robotic glove, which enables actuation of paralyzed hand by motor imagery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
Single (Outcomes Assessor)

盲法说明

The blinding will be carried out in such a way that the therapist will provide conventional therapy and assess the arm function without knowing the group that the patients belong to. The BCI Robot and Passive Robot will be administered by other study team member. A third party study team member not participating in the intervention will keep the log book which contains information regarding patients study ID and group. Randomization codes will be broken when all interventional and follow-up sessions were completed or when the patient decides to quit participation. The third party team member will unmask according to PI's request in this occasion.

入排标准

年龄范围
55 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 55-90 years regardless of lesion size, race
  • History of stroke less than 3 months prior to participation
  • Stroke type: ischemic or haemorrhagic
  • Fugl-Meyer motor score (FM score) of upper extremity impairment of 0-45 out of a maximum score of 66 on the Fugl-Meyer assessment scale
  • Ability to pay attention and maintain supported sitting for 1.5 hours continuously
  • Lack of or poor hand mobility (Medical Research Council Grade ≤ 2/5)
  • Able to give own consent
  • Able to comprehend and follow commands (Abbreviated Mental Test equal or more than 7)
  • Fulfil BCI resting brain states on initial screening.
  • Unilateral upper limb impairment

排除标准

  • Recurrent clinical stroke
  • Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension) 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 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 >1+ in any region, fixed joint contractures or joint replacements, patients with poor skin conditions which would contraindicate repetitive arm training, upper limb pain impeding movements with visual analogue scale (VAS score) >4/10, other conditions ensuing upper limb weakness, skull defect, polydactyly or amputation of fingers, and allergy to electrodes or adhesive gel

研究组 & 干预措施

BCI robot assisted hand therapy

Experimental

Brain-computer integration robot assisted hand therapy

干预措施: BCI Robot Assisted Hand Therapy (Device)

CPM robot assisted hand therapy

Active Comparator

Continue Passive Movement robot assisted hand therapy

干预措施: CPM Robot Assisted Hand Therapy (Device)

结局指标

主要结局

Action Research Arm Test

时间窗: 30 minutes

It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation

Grip Strength Test

时间窗: 5 minutes

The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.

Fugl-Meyer Assessment

时间窗: 20 minutes

It is designed to assess motor functioning, balance, sensation and joint functioning.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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