Brain Computer Interface (BCI) Technology for Stroke Hand Rehabilitation

NCT01287975 | Completed

• 1 other identifier: SERC Grant No: 092 148 0066
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke Rehabilitation; Brain Computer Interface; Upper Limb Rehabilitation; EEG-based Motor Imagery; Robotic Rehabilitation; Haptic Knob

Outcome Measures

Primary Outcomes (2)

• Action Research Arm Test

  Measures the change of upper limb motor function post-stroke

  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

• Fugl Myer Upper Limb Motor Assessment

  Measures changes in post-stroke upper limb movement

  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 Outcomes (5)

• Frenchay Arm Test

  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

• Grip Strength

  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

• Modified Ashworth Scale

  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

• Functional Independence Measure (Motor)

  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

• Pain Score

  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

Study Arms (3)

Standard Occupational Therapy

ACTIVE COMPARATOR

Standard Occupational Therapy for Wrist and Hand Training

Other: Occupational Therapy

BCI Haptic Knob

EXPERIMENTAL

BCI controlled robotic-assisted training for wrist and hand

Device: BCI Haptic Knob

Haptic Knob

EXPERIMENTAL

Robotic-assisted training for wrist and hand

Device: Haptic Knob

Interventions

Occupational Therapy OTHER

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.

Standard Occupational Therapy

BCI Haptic Knob DEVICE

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.

BCI Haptic Knob

Haptic Knob DEVICE

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.

Haptic Knob

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Institute for Infocomm Research: collaborator

Study Sites (1)

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, 569766, Singapore

Location

Related Publications (4)

• 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.

  PMID: 21096475 BACKGROUND

• 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.

  PMID: 29051688 BACKGROUND

• 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.

  PMID: 25120465 BACKGROUND

• 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.

  PMID: 24111256 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Karen SG Chua, MD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

SG (1)