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

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ClinicalTrials.gov Identifier: NCT03277508
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
National University, Singapore
Agency for Science, Technology and Research
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Device: BCI Robot Assisted Hand Therapy Device: CPM Robot Assisted Hand Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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)
Masking Description: 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.
Primary Purpose: Device Feasibility
Official Title: Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients
Actual Study Start Date : March 2, 2018
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : April 22, 2019

Arm Intervention/treatment
Experimental: BCI robot assisted hand therapy
Brain-computer integration robot assisted hand therapy
Device: BCI Robot Assisted Hand Therapy

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


Active Comparator: CPM robot assisted hand therapy
Continue Passive Movement robot assisted hand therapy
Device: CPM Robot Assisted Hand Therapy
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




Primary Outcome Measures :
  1. Action Research Arm Test [ Time Frame: 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

  2. Fugl-Meyer Assessment [ Time Frame: 20 minutes ]
    It is designed to assess motor functioning, balance, sensation and joint functioning.

  3. Grip Strength Test [ Time Frame: 5 minutes ]
    The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277508


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Agency for Science, Technology and Research
Investigators
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Principal Investigator: Jeong Hoon Lim National University Hospital, Singapore

Publications of Results:
Other Publications:
F.Z. Low, H.K. Yap, J.H. Lim, F. Nasrallah, J.C.H. Goh, C.H. Yeow. Wearable Soft Robotics for Rehabilitation. 8th Asian Pacific Conference on Biomechanics 2015 (Sapporo).
H.K. Yap, F. Nasrahllah, J.H. Lim, F.Z. Low, J.C.H. Goh, C.H. Yeow. MRC-Glove: A fMRI Compatible Soft Robotic Glove for Hand Rehabilitation Application, 14th IEEE/RAS-EMBS International Conference on Rehabilitation Robotics (ICORR 2015).
H.K. Yap, J.H. Lim, F. Nasrahllah, J.C.H. Goh, C.H. Yeow. A Soft Exoskeleton for Hand Assistive and Rehabilitation Application Page 8 using Pneumatic Actuators with Variable Stiffness, in IEEE Int. Conf. Robotics and Automation 2015.
H.K. Yap, J.C.H. Goh, C.H. Yeow. Design and Characterization of Soft Actuator for Hand Rehabilitation Application. 6th European Conference of the International Federation for Medical and Biological Engineering (MBEC 2014)
H.K. Yap, J.H. Lim, F. Nasrallah, J.C.H. Goh, C.H. Yeow. Customizable Pneumatic Bending Actuator for Finger Rehabilitation. Design of Medical Devices Conference Europe 2014 (Delft)
C.H. Yeow, A.T. Baisch, S.G. Talbot, C.J. Walsh. Differential spring stiffness design for finger therapy exercise device: bio-inspired from stiff pathological finger joints. ASME Journal of Medical Devices 2012
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03277508     History of Changes
Other Study ID Numbers: 2017/00312
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University Hospital, Singapore:
Brain-computer integration
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases