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

February 23, 2018 updated by: Chua Sui Geok, Karen, Tan Tock Seng Hospital

ARTS-BCI: Advanced Brain Computer Interface (BCI) Technology for Wrist and Hand Rehabilitation After Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 569766
        • Tan Tock Seng Hospital Rehabilitation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Occupational Therapy
Standard Occupational Therapy for Wrist and Hand Training
Other: Occupational Therapy

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.
EXPERIMENTAL: BCI Haptic Knob
BCI controlled robotic-assisted training for wrist and hand
Device: BCI Haptic Knob
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.
EXPERIMENTAL: Haptic Knob
Robotic-assisted training for wrist and hand
Device: Haptic Knob
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
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
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frenchay Arm Test
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
To measure performance in functional hand use 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
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
Use of grip dynamometer to measure changes in 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
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
Measure changes in spasticity of the affected limb
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)
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
Measures participation in activities of daily living.
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
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
Use of visual analogue scale of 0-10 for pain measurement
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Collaborators

Institute for Infocomm Research

Investigators

  • Principal Investigator: Karen SG Chua, MD, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (ESTIMATE)

February 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 23, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SERC Grant No: 092 148 0066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Occupational Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe