Stroke
Conditions
Keywords
Brain-Computer Interface; upper limb rehabilitation
Brief summary
One-third of patients who had stroke suffered persistent disabilities, and upper limb (UL) motor impairment is one of the main disabilities. Recent clinical studies had been conducted using non-invasive EEG-based BCI via motor imagery, for post-stroke rehabilitation, yielded motor improvement of 7.2 on the Fugl-Meyer Motor Assessment (FMA-UE)score in chronic stroke patients that is significantly better than standard care. However, all the stroke patients underwent the same one-size-fits-all treatment option involving all six different activities of daily living (ADL)-oriented tasks regardless of their impairment or ability. Investigators hypothesize that precision personalized stroke rehabilitation intervention that is tailored to the patient hold more promise than a one-size-fits-all stroke rehabilitation strategy.
Detailed description
1. To address the one-size-fits-all stroke rehabilitation strategy, RRIS will develop an Ability data-driven personalized stroke rehabilitation based on the stroke patient's UL impairment and motor ability, by first matching 6 UL tasks in RRIS Ability Database with the 6 ADL tasks of the BCI-SR Intervention via similarity indices. A personalized subset of ADL tasks treatment options is then generated by a data-driven recommendation based on the patient's ability, movement pattern of the treatment option and the normative data from the RRIS Ability Database. A multi-modal BCI is proposed to perform EEG subject-specific calibration using Near-infrared spectroscopy, NIRS to ensure motor imagery compliance. 2. stroke subjects with UL impairments (score 11-45 on the FMA-UE) will be recruited to undergo the UL tasks assessment at RRIS. They will then undergo the personalized stroke rehabilitation using the Multimodal EEG and NIRS-based BCI with Soft Robotic therapy for 1.5 hour over 6 weeks, 3 times a week. The effectiveness of the personalized stroke rehabilitation can then be retrospectively compared to the use of one-size-fits-all ADL tasks in the previous clinical trial.
Interventions
DEVICEMBCI-SR
Participants will be asked to wear and EEG+NIRS cap and a soft robotic glove on their stroke-impaired hand. The participant will be instructed to ask to imagine to picture moving the stroke-imparied hand in the mind. The brain signal (EEG and NIRS data) will be recorded as a reference. When the participant pictures this move again, upon detection of such imagined move by MBCI-SR system, the glove will be activated and assists the participants to perform a specific upper limb task based on individual ability. There are six different activities of daily living (ADL)-oriented tasks enacted through a virtual arm and virtual objects, which formed the visual feedback for the participants. These tasks include scanning goods, moving an object upward to a cabinet, using two hands to move a towel, pouring of water into a cup, eating action and fine motor movement of picking up a small block using two fingers. Training intensity is 1.5 hours for 3 times a week for 6 weeks, a total of 18 sessions.
Sponsors
Institute for Infocomm Research
Nanyang Technological University
Tan Tock Seng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* first ever stroke prior to clinical trial * Fugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximum score of 66 * ability to give own consent * ability to pay attention and maintain supported sitting for 1.5 hours continuously * able to comprehend and follow commands * fulfils BCI resting brain states on initial screening * unilateral upper limb impairment
Exclusion criteria
* recurrent stroke * inability to follow command and sit upright for 1.5 hours * hemi-spatial neglect * spasticity assessed by Modified Ashworth Scale more than 2/4 * History of Epilepsy * Fixed contracture / deformity of finger joints * upper limb pain impeding movements with visual analogy scale \> 4/10 * Severe aphasia or cognitive impairment despite visual aids * other conditions ensuing upper limb weakness * poor skin conditions * skull defect that might affect EEG or NIRS reading * allergy to electrodes or adhesive gel * significant vision and hearing impairment affecting participation * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer score of upper limb | Baseline | a measure for upper extremity, movement coordination and reflex action. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | Baseline | A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs |
Countries
Singapore
Contacts
Primary ContactChloe Lauha Chung, PhD
Backup ContactKai Keng Ang, PhD
Outcome results
None listed