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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Contact Information
Primary
Low Ai Mei Jaclyn
Jaclyn_AM_LOW@ttsh.com.sg
68894580
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 60
Treatments
Sham_comparator: Conventional supervised occupational therapy (CT)
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.
Active_comparator: HandyRehab (HR) with supervised training by OT
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.
Experimental: HandyRehab integrated with BCI (BCI-HR) with supervised training by OT
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.
Related Therapeutic Areas
Sponsors
Collaborators: Nanyang Technological University, National University of Singapore, Singapore University of Technology & Design
Leads: Tan Tock Seng Hospital

This content was sourced from clinicaltrials.gov