Status:
UNKNOWN
Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients
Lead Sponsor:
Alexandra Hospital
Collaborating Sponsors:
Jurong Community Hospital, Singapore
Roceso Technologies
Conditions:
Stroke
Eligibility:
All Genders
30-90 years
Phase:
NA
Brief Summary
This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE with Trigno Biofeedback (EMG sensors) in the inpatient rehabilitation setting. 1. Understanding the ability of the Es...
Detailed Description
This project proposes a study of 130 subjects in inpatient settings who have sustained their first-ever stroke prior to clinical trial enrolment. Participants are randomly assigned to 2 groups (EsoGLO...
Eligibility Criteria
Inclusion
- Aged 30-90 years regardless of lesion size, race
- Stroke type: ischemic or haemorrhagic
- Medically stable conditions
- Fugl-Meyer Assessment (FMA) of upper extremity impairment of 10-56 out of 66.
- Able to give own consent, comprehend and follow commands
- Able to sit upright and maintain sitting balance for at least 30 minutes
- Able to stay alert and focus on the tasks at least 30 minutes and more.
- Unilateral upper limb impairment
Exclusion
- Recurrent stroke
- Unstable medical conditions (e.g. heart attack, unstable blood pressure, infection, and etc.) or anticipated life expectancy of \<1 year.
- 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 ≥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).
- Poor trunk control or postural hypotension.
Key Trial Info
Start Date :
July 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05995665
Start Date
July 11 2023
End Date
June 30 2025
Last Update
August 16 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Alexandra Hospital
Singapore, Singapore
2
Jurong Community Hospital
Singapore, Singapore