Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): BCI Robot Assisted Hand Therapy; CPM Robot Assisted Hand Therapy
Intervention type(s): Device; Device
Intervention description(s): 18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of BCI Robot and 30 minutes of the standard hand therapy).
Session 1-3. Peg game: Lateral movement of gears/cups Session 4-6. Moving cups onto a shelf: Elevation process for the arm, small cups to be used.
Session 7-9. Carrying of basket: Heavier load to be used, patient to hold the basket by the handles at the side, not by its base.
Session 10-12. Opening bottle + pouring into a cup: Training of ADL Session 13-15. Eating: Use of a modified spoon to train ADL Session 16-18. Box and blocks: Precise index finger and thumb control; 18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of Passive Robot and 30 minutes of the standard hand therapy).The procedure will include the following: Session 1-18: Continuous passive motion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomization stratification method, with a computer generated random sequence will be used. Subjects will be grouped in strata according to their Fugl-Meyer scores(0-28 vs 29-45) and randomized separately according to a block randomization to receive either of following treatments:(1) Treatment A: 18 sessions for 6 weeks of 60 minutes of passive robot-assisted hand therapy+ 30 minutes of standard hand therapy.(2) Treatment B: 18 sessions for 6 weeks of 60 minutes of BCI controlled robot-assisted hand therapy + 30 minutes of standard hand therapy.
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: Brain-computer integration