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

NCT06076928 | Recruiting

• 1 other identifier: DSRB 2022/00694
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Brain Computer Interface; Hand exoskeleton robot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Fugl-Meyer Motor Assessment (FMA) scale

  Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

• Grip Strength (kg)

  Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

• Box and Block Test (BBT)

  Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

• Nine Hole Peg Test (NHPT)

  Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

• Self-efficacy outcomes by UPSET (upper limb self-efficacy test)

  Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

Other Outcomes (2)

• Modified Ashworth Scale (MAS)

  Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)

• Visual Analogue Scale (self-reported pain score)

  Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

Study Arms (3)

Conventional supervised occupational therapy (CT)

SHAM COMPARATOR

CT consists of standard occupational therapy for hand function which includes but not limited to the following treatment (1) passive and active mobilisation; (2) spasticity management; (3) training with use of various modalities/equipment; (4) gross and fine motor training including reach and grasp/release functions, and object manipulation; (5) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.

Other: Standard Treatment of Care

HandyRehab (HR) with supervised training by OT

ACTIVE COMPARATOR

HR training consists of (1) passive and active mobilisation (2) spasticity management (3) gross motor training with HR applied (4) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.

Device: HandyRehab (HR); Other: Standard Treatment of Care

HandyRehab integrated with BCI (BCI-HR) with supervised training by OT

EXPERIMENTAL

BCI-HR training consists of (1) passive and active mobilisation (2) spasticity management (3) gross motor training with BCI-HR applied (4) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.

Device: Brain Computer Interface integrated HandyRehab platform (BCI-HR); Other: Standard Treatment of Care

Interventions

Brain Computer Interface integrated HandyRehab platform (BCI-HR) DEVICE

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 integrated with BCI (BCI-HR) with supervised training by OT

HandyRehab (HR) DEVICE

A wearable hand robotic glove approved by Health Sciences Authority, class I commercial device

HandyRehab (HR) with supervised training by OT

Standard Treatment of Care OTHER

Standard Conventional Occupational Therapy

Conventional supervised occupational therapy (CT); HandyRehab (HR) with supervised training by OT; HandyRehab integrated with BCI (BCI-HR) with supervised training by OT

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-85 years, males and females
• First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist/neurosurgeon/CT/MRI imaging
• \> 16 weeks post stroke
• Hemiplegic pattern of post-stroke weakness
• MRC ≥ 2/5 motor power and above for shoulder abduction \& elbow flexion
• MRC 0 to 4/5 motor power and above for finger flexors \&/or extensors of thumb, index, middle fingers
• Screening Fugl-Meyer wrist hand sub score \<18/24
• Spasticity MAS \<3 for thumb, index, and middle fingers
• Able to discriminate thumb and index sensation to pain
• Hand sizes within 170-200mm (length) \&75-85mm (width), compatible with HandyRehab robotic glove
• BCI compatible brain states using a standardised screening protocol
• Able to understand simple commands with Mini Mental state examination scores MMSE \> 21/30)
• Able to give informed consent
• Subjects who are unable to clear BCI screening 11. will be randomised to either CT or HR groups.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Nanyang Technological University: collaborator
• Singapore University of Technology & Design: collaborator
• National University of Singapore: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Karen Chua

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Low Ai Mei Jaclyn

CONTACT

68894580; Jaclyn_AM_LOW@ttsh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors (occupational therapist performing measurements/outcome) not involved in participant training will be blinded to assignments of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a prospective, single-centre, single blinded 3-arm randomised controlled trial to compare upper extremity motor and functional outcomes and health related quality of life (HR-QOL) of 3 treatment modalities which are fully clinic-based and supervised by trained occupational therapists (OT). Participants will undergo dose matched training interventions with 1:1 allocation using single-blinded RCT.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 11, 2023
• Study Start: August 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)