Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients

Launched by ALEXANDRA HOSPITAL · Aug 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the EsoGLOVE, which is a soft robotic glove designed to help stroke patients improve their hand function during rehabilitation. The goal is to see if the EsoGLOVE, combined with special sensors that track muscle activity, can assist patients in doing exercises and daily tasks, ultimately helping them recover better and regain movement in their hands. The researchers also want to understand how cost-effective this device is for healthcare.

To participate in this study, you need to be between 30 and 90 years old and have had an ischemic or hemorrhagic stroke. You should be in stable health and able to follow simple commands. Participants will be involved in exercises using the EsoGLOVE while being monitored for their progress. It’s important to note that patients with certain conditions, such as severe depression or unstable medical issues, won't be eligible for this trial. Overall, this study aims to gather important information that could lead to better rehabilitation options for stroke patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 30-90 years regardless of lesion size, race
• • 2. Stroke type: ischemic or haemorrhagic
• • 3. Medically stable conditions
• • 4. Fugl-Meyer Assessment (FMA) of upper extremity impairment of 10-56 out of 66.
• • 5. Able to give own consent, comprehend and follow commands
• • 6. Able to sit upright and maintain sitting balance for at least 30 minutes
• • 7. Able to stay alert and focus on the tasks at least 30 minutes and more.
• • 8. Unilateral upper limb impairment
• Exclusion Criteria:
• • 1. Recurrent stroke
• • 2. Unstable medical conditions (e.g. heart attack, unstable blood pressure, infection, and etc.) or anticipated life expectancy of \<1 year.
• • 3. Cognitive and communicative impairment (e.g. severe receptive aphasia, inattention, learning difficulty, and etc).
• • 4. History of severe depression or active psychiatric disorder.
• • 5. Severe spasticity (Modified Ashworth scale ≥2), joint contractures or deformity, poor skin conditions (e.g. irritated skin, open wounds), amputation of fingers, and allergic condition (e.g. patients with allergies to adhesive gel).
• • 6. Poor trunk control or postural hypotension.