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Completed
NCT05995665
Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients
Conditions: Stroke
Sex: All
Ages: 21 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 61
Sponsor: Alexandra Hospital
Location: Alexandra Hospital Singapore
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.
Eligibility Criteria
Inclusion Criteria:
1. Aged 21-90 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 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.
5. Able to give own consent, comprehend and follow commands
6. Able to sit upright and maintain sitting balance for at least 45 minutes
7. Able to stay alert and focus on the tasks at least 45 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 \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).
6. Poor trunk control or postural hypotension.
Source: ClinicalTrials.gov (NCT05995665). StuddyBuddy aggregates publicly available trial information.