Assistive robotic glove for stroke rehabilitation
Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients
This study is testing whether a special robotic glove can help stroke patients improve their hand function during rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 30 Years to 90 Years |
| Sex | All |
| Sponsor | Alexandra Hospital Academic / other |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT05995665 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness and feasibility of the EsoGLOVE, equipped with Trigno Biofeedback (EMG sensors), in helping stroke patients improve hand function during inpatient rehabilitation. The study involves 130 participants who will be randomly assigned to either the EsoGLOVE group or the GRASP group, receiving additional therapy for three weeks. Participants will undergo intensive rehabilitation alongside the use of the device, with follow-up assessments conducted after discharge to measure outcomes. The study aims to generate evidence for the device's clinical application and assess its cost-effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30-90 who have experienced their first-ever stroke and have unilateral upper limb impairment.
Not a fit: Patients with recurrent strokes, unstable medical conditions, or severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance motor function and recovery in stroke patients.
How similar studies have performed: While the use of robotic devices in rehabilitation is gaining traction, this specific approach with the EsoGLOVE is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore and 1 other locations
- Alexandra Hospital — Singapore, Singapore (Recruiting)
- Jurong Community Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Pui Kit Tam, MBBS — Alexandra Hospital
- Study coordinator: Pui Kit Tam, MBBS
- Email: pui_kit_tam@nuhs.edu.sg
- Phone: +65 -6779 5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.