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Brain Computer Interface (BCI) Technology for Stroke Hand Rehabilitation (ARTS-BCI)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Occupational Therapy
BCI Haptic Knob
Haptic Knob
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke Rehabilitation, Brain Computer Interface, Upper Limb Rehabilitation, EEG-based Motor Imagery, Robotic Rehabilitation, Haptic Knob

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 21-80 years with first-ever clinical stroke, within 1-24 months onset.
  2. Stroke type: ischemic or haemorhagic.
  3. Fugl-Meyer motor score of the upper limb range from 10-50 or
  4. Motor power MRC grade 3-5 in shoulder abductors and elbow flexors, and 0-3 in wrist dorsiflexors and finger flexors
  5. Ability to pay attention and maintain supported sitting for 1 hour continuously.
  6. Able to give own consent and understand simple instructions
  7. Fulfills BCI and Haptic knob physical screening trial.

Exclusion Criteria:

  1. 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)
  2. Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids.
  3. Epilepsy, severe depression or psychiatric disorder.
  4. Recurrent stroke
  5. Skull defect as this would affect physical fit of EEG cap interface.
  6. Local arm factors: Severe spasticity Modified Ashworth scale >2 in any region, visual analogue scale (VAS score) >4/10, fixed joint contracture , patients with poor skin conditions, infections or eczema which may potentially be worsened by robotic shell contact.

Sites / Locations

  • Tan Tock Seng Hospital Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Occupational Therapy

BCI Haptic Knob

Haptic Knob

Arm Description

Standard Occupational Therapy for Wrist and Hand Training

BCI controlled robotic-assisted training for wrist and hand

Robotic-assisted training for wrist and hand

Outcomes

Primary Outcome Measures

Action Research Arm Test
Measures the change of upper limb motor function post-stroke
Fugl Myer Upper Limb Motor Assessment
Measures changes in post-stroke upper limb movement

Secondary Outcome Measures

Frenchay Arm Test
To measure performance in functional hand use post stroke
Grip Strength
Use of grip dynamometer to measure changes in grip strength
Modified Ashworth Scale
Measure changes in spasticity of the affected limb
Functional Independence Measure (Motor)
Measures participation in activities of daily living.
Pain Score
Use of visual analogue scale of 0-10 for pain measurement

Full Information

First Posted
January 26, 2011
Last Updated
February 23, 2018
Sponsor
Tan Tock Seng Hospital
Collaborators
Institute for Infocomm Research
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1. Study Identification

Unique Protocol Identification Number
NCT01287975
Brief Title
Brain Computer Interface (BCI) Technology for Stroke Hand Rehabilitation
Acronym
ARTS-BCI
Official Title
ARTS-BCI: Advanced Brain Computer Interface (BCI) Technology for Wrist and Hand Rehabilitation After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Institute for Infocomm Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is carried out to find out if Brain Computer Interface (BCI) technology or BCI technology coupled with robotic technology using a Haptic Knob will benefit patients with arm paralysis after stroke. BCI uses EEG-based motor imagery to detect user's thinking abilities which control motor movement. Haptic Knob is a novel robotic device, which specifically trains the wrist and hand with intensive repetitions in a supported environment.
Detailed Description
Physical therapy approaches are the de facto rehabilitation for stroke, which involve human therapists to assist stroke patients in recovering their motor ability. Modern rehabilitation technologies include robotics, functional electrical stimulation, transcranial magnetic stimulation and virtual reality. Robotic rehabilitation alleviates the labor-intensive aspects of physical rehabilitation by human therapists and could potentially improve the productivity of stroke rehabilitation. However, it is fundamentally based on movement repetition with visual feedback that helps stroke patients improve motor ability in their weak stroke-affected arms and legs. However, the robot is still able to move the weak part of the patient even if the patient is not attentive towards the training and thus the robotic training becomes a passive activity. In contrast, BCI-based robotic training works by ensuring active engagement by the hemiparetic patients in making a volitional movement. In addition, hemiplegic or locked-in stroke patients who do not have any motor power on the affected limbs are then able to engage and perform a volitional movement on these affected limbs. BCI-based robotic rehabilitation fills this gap by detecting the motor intent of hemiplegic patients from the Electroencephalogram (EEG) signals to drive the robotic rehabilitation. This BCI-based robotic rehabilitation for stroke research project was jointly conducted by Tan Tock Seng Hospital (TTSH), National Neuroscience Institute (NNI) and Institute for Infocomm Research (I2R). Preliminary clinical trials performed at TTSH have shown that stroke patients can operate the BCI as effective as healthy subjects. Specifically, this research project will address the following gaps in the area of rehabilitation for stroke: Single-modal BCI - The current system employs a single modal non-invasive EEG-based BCI that detects motor intent using at least 2.5 seconds of EEG data. Hence, the research of an advanced multi-modal BCI such as synergizing near-infrared spectroscopy with EEG to yield a more responsive and effective BCI-based robotic rehabilitation system is proposed. Standard therapy - The current system employs a standard therapy for all the stroke patients. However, physiotherapists and occupational therapists usually adopt a more individualized therapy for each stroke patients. Hence, research on an individualized therapy for each stroke patient according to his or her learning rate and neurological insult is proposed. Only physiological rehabilitation - The current system only performs physiological rehabilitation of motor functions of stroke patients. Currently some validated scales for post-stroke depression such as Beck depression inventory, CES-D, Zung scale, State trait, HADS etc are difficult to administer in stroke patients who cannot participate with assessment due to impaired language or cognitive abilities. Hence an advanced BCI-based rehabilitation system that also detects the mental state of the stroke patient is proposed to cover both physiological and psychological rehabilitation. Upper Limb rehabilitation - The current system which uses the clinically-proven MIT Manus robotic rehabilitation system, only performs upper limb rehabilitation for stroke patients in gross reach patterns. Human hand skills, in contrast, consist of more complex manipulation movement patterns which can be intervened by BCI-based robotic rehabilitation. Hence, an advanced BCI-based rehabilitation system that covers the hand function is proposed to cover the rehabilitation of the entire upper extremity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke Rehabilitation, Brain Computer Interface, Upper Limb Rehabilitation, EEG-based Motor Imagery, Robotic Rehabilitation, Haptic Knob

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Occupational Therapy
Arm Type
Active Comparator
Arm Description
Standard Occupational Therapy for Wrist and Hand Training
Arm Title
BCI Haptic Knob
Arm Type
Experimental
Arm Description
BCI controlled robotic-assisted training for wrist and hand
Arm Title
Haptic Knob
Arm Type
Experimental
Arm Description
Robotic-assisted training for wrist and hand
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Intervention Description
Use of conventional manual facilitation and function-based training used in conventional occupational therapy training for post-stroke upper limb weakness. Training is modelled along the neurodevelopmental techniques and will include stretching, tone management, weight bearing exercises, movement facilitation, selfcare training, arm ergometry by arm bicycles and grip strength training. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively.
Intervention Type
Device
Intervention Name(s)
BCI Haptic Knob
Intervention Description
BCI based robotic rehabilitation works by detecting the motor intent of the user from electroencephalogram signals to drive the robotic rehabilitation via Haptic Knob. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively.
Intervention Type
Device
Intervention Name(s)
Haptic Knob
Intervention Description
Haptic Knob is an upper limb robot designed for use in robotic-assisted rehabilitation of the stroke wrist and hand. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively.
Primary Outcome Measure Information:
Title
Action Research Arm Test
Description
Measures the change of upper limb motor function post-stroke
Time Frame
Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Title
Fugl Myer Upper Limb Motor Assessment
Description
Measures changes in post-stroke upper limb movement
Time Frame
Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Secondary Outcome Measure Information:
Title
Frenchay Arm Test
Description
To measure performance in functional hand use post stroke
Time Frame
Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Title
Grip Strength
Description
Use of grip dynamometer to measure changes in grip strength
Time Frame
Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Title
Modified Ashworth Scale
Description
Measure changes in spasticity of the affected limb
Time Frame
Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Title
Functional Independence Measure (Motor)
Description
Measures participation in activities of daily living.
Time Frame
Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion
Title
Pain Score
Description
Use of visual analogue scale of 0-10 for pain measurement
Time Frame
Measurements at 2 weeks prior to intervention, just before start of intervention, at midpoint of intervention, at completion of intervention, at 3 months post intervention and at 6 months post-intervetion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 21-80 years with first-ever clinical stroke, within 1-24 months onset. Stroke type: ischemic or haemorhagic. Fugl-Meyer motor score of the upper limb range from 10-50 or Motor power MRC grade 3-5 in shoulder abductors and elbow flexors, and 0-3 in wrist dorsiflexors and finger flexors Ability to pay attention and maintain supported sitting for 1 hour continuously. Able to give own consent and understand simple instructions Fulfills BCI and Haptic knob physical screening trial. Exclusion Criteria: 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. Epilepsy, severe depression or psychiatric disorder. Recurrent stroke Skull defect 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 contracture , patients with poor skin conditions, infections or eczema which may potentially be worsened by robotic shell contact.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen SG Chua, MD
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital Rehabilitation Centre
City
Singapore
ZIP/Postal Code
569766
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
21096475
Citation
Ang KK, Guan C, Chua KS, Ang BT, Kuah C, Wang C, Phua KS, Chin ZY, Zhang H. Clinical study of neurorehabilitation in stroke using EEG-based motor imagery brain-computer interface with robotic feedback. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:5549-52. doi: 10.1109/IEMBS.2010.5626782.
Results Reference
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PubMed Identifier
29051688
Citation
Arvaneh M, Guan C, Ang KK, Ward TE, Chua KSG, Kuah CWK, Ephraim Joseph GJ, Phua KS, Wang C. Facilitating motor imagery-based brain-computer interface for stroke patients using passive movement. Neural Comput Appl. 2017;28(11):3259-3272. doi: 10.1007/s00521-016-2234-7. Epub 2016 Mar 4.
Results Reference
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PubMed Identifier
25120465
Citation
Ang KK, Guan C, Phua KS, Wang C, Zhou L, Tang KY, Ephraim Joseph GJ, Kuah CW, Chua KS. Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke. Front Neuroeng. 2014 Jul 29;7:30. doi: 10.3389/fneng.2014.00030. eCollection 2014.
Results Reference
background
PubMed Identifier
24111256
Citation
Ang KK, Guan C, Chua KS, Phua KS, Wang C, Chin ZY, Zhou L, Tang KY, Joseph GJ, Kuah C. A clinical study of motor imagery BCI performance in stroke by including calibration data from passive movement. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6603-6. doi: 10.1109/EMBC.2013.6611069.
Results Reference
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Brain Computer Interface (BCI) Technology for Stroke Hand Rehabilitation

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