Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients
Singapore61 participantsStarted 2023-07-11
Plain-language summary
This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE in the inpatient rehabilitation setting. 1. Understanding the ability of the EsoGLOVE in providing exercise and assisting stroke patients with completing hand functional tasks, eventually improves patients' motor function and neural recovery.2. To generate evidence on this innovative device and further deploy it in clinical practice. A Health Technology Assessment (HTA) will be generated from this study to evaluate the cost-effectiveness of the intervention.
Who can participate
Age range
21 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 21-90 years regardless of lesion size, race
. Stroke type: ischemic or haemorrhagic
. Medically stable conditions
. Fugl-Meyer Assessment (FMA) of upper extremity impairment from 8-47 out of 66, or FMA of upper extremity impairment from 48-56 out of 66 if hand and wrist subscale is not full score and may still potentially benefit from study programme.
. Able to give own consent, comprehend and follow commands
. Able to sit upright and maintain sitting balance for at least 45 minutes
. Able to stay alert and focus on the tasks at least 45 minutes and more.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Unstable medical conditions (e.g. heart attack, unstable blood pressure, infection, and etc.) or anticipated life expectancy of \<1 year.
. Significant cognitive and communicative impairment (e.g. severe receptive aphasia, inattention, learning difficulty, and etc).
. History of severe depression or active psychiatric disorder.
. Severe spasticity (Modified Ashworth scale \>3) of the affected distal muscles, 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).