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

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Brain Computer Interface integrated HandyRehab platform (BCI-HR)
HandyRehab (HR)
Standard Treatment of Care
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Brain Computer Interface, Hand exoskeleton robot

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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

Sites / Locations

  • Tan Tock Seng Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Experimental

Arm Label

Conventional supervised occupational therapy (CT)

HandyRehab (HR) with supervised training by OT

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

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Grip Strength (kg)
Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands
Box and Block Test (BBT)
Measures unilateral gross manual dexterity.
Nine Hole Peg Test (NHPT)
Measures finger dexterity in stroke patients.
Self-efficacy outcomes by UPSET (upper limb self-efficacy test)
Questionnaire to measure self-efficacy in various tasks after stroke.
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.
Patient reported Outcome Measures (PROMs) using subjective scales (Likert 0-5)
Measures patient's opinion on the usability of HR and BCI-HR
Montreal Cognitive Assessment (MOCA)
Screening assessment to determine cognitive impairment.
Rey Auditory Verbal Learning Test (RAVLT)
Cognitive assessment to evaluate verbal learning and memory
Trail Making Test (TMT)
Neuropsychological test assessing visual attention and task switching.
Digit Span
Cognitive Assessment of both forward and backward variants.
Controlled Oral Word Association Test (COWAT)
Neuropsychological measure of verbal fluency.

Full Information

First Posted
September 20, 2023
Last Updated
October 4, 2023
Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University, Singapore University of Technology & Design, National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT06076928
Brief Title
Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation
Official Title
Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation: A 3-arm Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University, Singapore University of Technology & Design, National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Brain Computer Interface, Hand exoskeleton robot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Assessors (occupational therapist performing measurements/outcome) not involved in participant training will be blinded to assignments of participants.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional supervised occupational therapy (CT)
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
HandyRehab (HR) with supervised training by OT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HandyRehab integrated with BCI (BCI-HR) with supervised training by OT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Brain Computer Interface integrated HandyRehab platform (BCI-HR)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
HandyRehab (HR)
Intervention Description
A wearable hand robotic glove approved by Health Sciences Authority, class I commercial device
Intervention Type
Other
Intervention Name(s)
Standard Treatment of Care
Intervention Description
Standard Conventional Occupational Therapy
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT) Score
Description
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.
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Secondary Outcome Measure Information:
Title
Fugl-Meyer Motor Assessment (FMA) scale
Description
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Title
Grip Strength (kg)
Description
Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Title
Box and Block Test (BBT)
Description
Measures unilateral gross manual dexterity.
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Title
Nine Hole Peg Test (NHPT)
Description
Measures finger dexterity in stroke patients.
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Title
Self-efficacy outcomes by UPSET (upper limb self-efficacy test)
Description
Questionnaire to measure self-efficacy in various tasks after stroke.
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Title
Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)
Description
Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function.
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Title
Patient reported Outcome Measures (PROMs) using subjective scales (Likert 0-5)
Description
Measures patient's opinion on the usability of HR and BCI-HR
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
Title
Montreal Cognitive Assessment (MOCA)
Description
Screening assessment to determine cognitive impairment.
Time Frame
Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Title
Rey Auditory Verbal Learning Test (RAVLT)
Description
Cognitive assessment to evaluate verbal learning and memory
Time Frame
Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Title
Trail Making Test (TMT)
Description
Neuropsychological test assessing visual attention and task switching.
Time Frame
Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Title
Digit Span
Description
Cognitive Assessment of both forward and backward variants.
Time Frame
Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Title
Controlled Oral Word Association Test (COWAT)
Description
Neuropsychological measure of verbal fluency.
Time Frame
Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Other Pre-specified Outcome Measures:
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
Title
Visual Analogue Scale (self-reported pain score)
Description
Unidimensional measure of pain intensity; "0" being no pain and "10" being worst pain.
Time Frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Low Ai Mei Jaclyn
Phone
68894580
Email
Jaclyn_AM_LOW@ttsh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Chua
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Low Ai Mei Jaclyn
Email
Jaclyn_AM_LOW@ttsh.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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