Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation: A 3-arm Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06076928
• Other study ID #: DSRB 2022/00694
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Tan Tock Seng Hospital
• Contact: Low Ai Mei Jaclyn
• Phone: 68894580
• Email: Jaclyn_AM_LOW[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper extremity (UE) recovery remains a huge rehabilitation challenge with largely incomplete recovery of the upper limb post stroke. This is due to heavier priorities placed on other stroke competencies such as mobility, activities of daily living training and home integration which results in suboptimal amounts of time spent in upper limb training post stroke.

In this study the investigators plan to pilot brain computer interface (BCI) integrated wearable hand robotic glove (HandyRehab) system for upper limb stroke rehabilitation.

Description:

Robot-aided therapy have shown promising results in rehabilitation recovery in stroke patients while reducing strain and effort for both the therapist and suitable patients.

HandyRehab (HR) is a portable, wearable hand robotic glove used for functional training. The integration of Brain Computer Interface (BCI) platform with HR provides an alternative way of communication or intended movement through end-effectors for stroke and potentially facilitate neuroplasticity, improving motor functions.

This study aims to validate the usability of intensive training with HandyRehab (HR) compared with conventional occupational therapy (CT). Feasibility and safety of the novel BCI-HR will be examined and objective measures of clinical efficacy will be compared across all 3 platforms.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age 21-85 years, males and females

2. First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist/neurosurgeon/CT/MRI imaging

3. > 16 weeks post stroke

4. Hemiplegic pattern of post-stroke weakness

5. MRC = 2/5 motor power and above for shoulder abduction & elbow flexion

6. MRC 0 to 4/5 motor power and above for finger flexors &/or extensors of thumb, index, middle fingers

7. Screening Fugl-Meyer wrist hand sub score <18/24

8. Spasticity MAS <3 for thumb, index, and middle fingers

9. Able to discriminate thumb and index sensation to pain

10. Hand sizes within 170-200mm (length) &75-85mm (width), compatible with HandyRehab robotic glove

11. BCI compatible brain states using a standardised screening protocol

12. Able to understand simple commands with Mini Mental state examination scores MMSE > 21/30)

13. Able to give informed consent

• Subjects who are unable to clear BCI screening 11. will be randomised to either CT or HR groups.

Exclusion Criteria:

Neurological

• Recurrent stroke

• Diagnosis of neurodegenerative disease; e.g. Parkinson's' disease, Dementia, ALS

Medical:

• unstable medical or neurological conditions, life expectancy <6 months, end-organ renal failure on dialysis, severe heart failure, postural hypotension, history of uncontrolled sepsis, epilepsy with seizure within 3 months of informed consent, skin conditions which could potentially be worsened by wearable robot (ulcers, open wounds, eczema, infections etc)

Postural:

• Unable to tolerate upright posture or sit unaided for < 90min with rest breaks

• Cognitive/behavioural/visual:

• Severe dysphasia/aphasia, severe visual neglect/blindness, untreated severe depression, psychiatric illness, unable to understand study requirements

Upper limb:

• Moderate to severe spasticity (Modified Ashworth scale MAS =2)

• Hand/arm related pain (VAS Pain = 5/10),

• Presence of finger contractures, reduced functional range of motion, limiting functional wrist/finger movements, active fractures or arthritis with deformities

• Severe limb ataxia/apraxia

• Severe post stroke hemi-anaesthesia in affected UE

BCI incompatibility:

• Motor imagery EEG signals unable to be detected

• Presence of craniectomy skull defect (affecting BCI cap fit and electrode contact)

• Concomitant participation in other interventional research trials

• Resident of nursing home or overseas country which may compromise attendance at research site

• Pregnant or lactating females will not be allowed to participate

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Brain Computer Interface integrated HandyRehab platform (BCI-HR)
To test the usability, safety and efficacy of an experimental prototype of a wearable hand robotic glove integrated with brain computer interface system being developed and researched.
• HandyRehab (HR)
A wearable hand robotic glove approved by Health Sciences Authority, class I commercial device

Other:
• Standard Treatment of Care
Standard Conventional Occupational Therapy

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Nanyang Technological University, National University of Singapore, Singapore University of Technology & Design

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified Ashworth Scale (MAS)	Measures the level of spasticity at the elbow and finger flexors of proximal interphalangeal joint regions; scored from "0 to 4" with "4" indicating affected part is more spastic in flexion/extension.	Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Other	Visual Analogue Scale (self-reported pain score)	Unidimensional measure of pain intensity; "0" being no pain and "10" being worst pain.	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Primary	Action Research Arm Test (ARAT) Score	Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary	Fugl-Meyer Motor Assessment (FMA) scale	Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary	Grip Strength (kg)	Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary	Box and Block Test (BBT)	Measures unilateral gross manual dexterity.	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary	Nine Hole Peg Test (NHPT)	Measures finger dexterity in stroke patients.	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary	Self-efficacy outcomes by UPSET (upper limb self-efficacy test)	Questionnaire to measure self-efficacy in various tasks after stroke.	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary	Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)	Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function.	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary	Patient reported Outcome Measures (PROMs) using subjective scales (Likert 0-5)	Measures patient's opinion on the usability of HR and BCI-HR	Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary	Montreal Cognitive Assessment (MOCA)	Screening assessment to determine cognitive impairment.	Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Secondary	Rey Auditory Verbal Learning Test (RAVLT)	Cognitive assessment to evaluate verbal learning and memory	Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Secondary	Trail Making Test (TMT)	Neuropsychological test assessing visual attention and task switching.	Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Secondary	Digit Span	Cognitive Assessment of both forward and backward variants.	Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Secondary	Controlled Oral Word Association Test (COWAT)	Neuropsychological measure of verbal fluency.	Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)