NCT06076928

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
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.
DEVICE	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

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-10-11
• Last updated: 2025-09-09

Locations

1 site across 1 country: Singapore